Physical Therapy- Journal of the APTA, Volume 90, Issue 1 (January 2010)

January 2010  Volume 90  Number 1 Research Reports 14 Ultrasound for Soft Tissue Shoulder Pathology 26 Prognosis ...

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January 2010  Volume 90  Number 1

Research Reports 14

Ultrasound for Soft Tissue Shoulder Pathology

26

Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation

43

Early Measures After Unilateral Total Knee Arthroplasty

55

Effects of Dorsiflexor Muscle Functional Electrical Stimulation on Poststroke Gait

67

Strength and Stooping, Crouching, or Kneeling Difficulty in Older Adults

75

Use of Reflection in Clinical Decision Making

89

Measuring Skill in Walking of Older Adults

Case Report 100

Perspective 110

Hallux Valgus and the First Metatarsal Arch Segment

CARE V Conference Series 121

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Hospital-Based Outpatient Direct Access to Physical Therapy Services

Team Rehabilitation Care After Arthroplasty for Osteoarthritis

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Gain quick and easy access to clinical research. Get free access to full-text articles in more than 1,000 health care periodicals with APTA’s Open Door portal. Open Door also features full-text Cochrane systematic reviews, Medline, an expanded Current Research in Physical Therapy section, open access resources, and more.

Access Hooked on Evidence, APTA’s online database, which contains current research evidence on the effectiveness of physical therapy interventions. Plus, you can earn free CEUs for your contributions.

Visit Physical Therapy (PTJ) on the Web, powered by HighWire Press, which hosts more than 900 journals and the largest repository of free, full-text, peer-reviewed content, including BMJ and JAMA.

Experience the Benefits of APTA Membership! For more details about any of APTA’s exclusive member benefits, visit www.apta.org.

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at CSM 2010 Reserve These Dates and Times for PTJ Sessions at CSM 2010 Stepping Forward With Gait Rehabilitation Friday, February 19

8:00–11:00 am

0.30 CEUs

Researchers who contributed to PTJ’s Special Series on Gait share the highlights of their work and demonstrate cutting-edge and future directions in gait assessment and rehabilitation. Get a crash course in new knowledge related to theoretical frameworks; insights from a variety of gait paradigms; measurement strategies, such as accelerometry for measuring community ambulation in stroke and ambulatory self-efficacy in frail older adults; and gait applications such as virtual reality, mental practice, and body–weight supported treadmill training. You’ll also identify exciting opportunities in both research and practice. PTJ’s Special Series on Gait, to be published online ahead of print in December and in print in February 2010, honors Dr Jacquelin Perry and her many invaluable contributions to the field of gait rehabilitation overmore than 40 years. Led by Special Series Editors Janice Eng, PT, PhD, and Sara Mulroy, PT, PhD. Speakers: Diane Damiano, PT, PhD; Arthur Kuo, PhD; Francine Malouin, PT, PhD.

How to Design and Conduct RCTs: Real-World Considerations Friday, February 19

4:00–6:45 pm

0.28 CEUs

Ever wish you could consult with a group of experienced investigators who have successfully conducted randomized trials and published the results? Wish granted! At this session, you have the undivided attention of an international panel of both physical therapist and non–physical therapist researchers who will share their strategies with you. Benefit from concrete examples and small-group discussion that will focus not only on design but on some of the key issues involved in actually conducting trials. Led by Editorial Board Members Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP, and Christopher G. Maher, PT, PhD.

PTJ Lunch for Authors and Reviewers Saturday, February 20

12:00–2:00 pm

0.25 CEUs

If you’re an author or a reviewer, you work hard! PTJ salutes you! Take advantage of the collective expertise of PTJ’s Editorial Board; come with your questions and your appetite. Authors want to “get it right,” reduce review time, and get published; reviewers want to enhance their evaluative skills, use their time efficiently, and build their scholarly contributions. Discuss the challenges, and learn new strategies. Led by Editor-in-Chief Rebecca Craik, PT, PhD, FAPTA; Editorial Board Member Patricia Ohtake, PT, PhD; and members of PTJ’s Editorial Board.

CSM 2010

SAN DIEGO

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Feb ruary 17-20

American Physical Therapy Association’s Combined Sections Meeting

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Next month—in PTJ or online at ptjournal.org: Stepping Forward With Gait Rehabilitation Special Series in Honor of Dr. Jacquelin Perry

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Dynamic Principles of Gait

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Effects of Dual Tasking, Prioritization, Age, and Sex on Gait

Cognitive Load and Dual-Task Performance During Locomotion Poststroke

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Split-Belt and Other Locomotor Adaptation Paradigms

A Treatment for Adults With Stiff Knee Gait

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Meaningful Gait Speed Improvement Poststroke

Strength Training and Gait Kinematics

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Responsiveness to a BodyWeight–Supported Treadmill Training Program Poststroke

Parkinson Disease: EvidenceBased Physical Therapy for Gait Disorders

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Joint Kinematics and Muscle Demands in Elliptical Training and Walking

• • •

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Daily Stepping in Individuals With Motor Incomplete SCI

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Mental Practice for Relearning Locomotor Skills

“Just clicking around the site and wanted to give a huge ‘thumbs umbs up!’ PTJ…used to sit in my inbox and got quickly browsed. wsed. Now I have trouble finding time to explore all the value! Video, podcasts, tweets, applicable Journal entries entries…” —Jim m Glinn, PT, P DPT, OCS

Visit ptjournal.org for enhanced features, including articles published ahead of print! Physical Therapy (PTJ)—APTA’s peer-reviewed scholarly

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Physical Therapy Journal of the American Physical Therapy Association

Editorial Office Managing Editor / Associate Director of Publications: Jan P. Reynolds, [email protected] PTJ Online Editor / Assistant Managing Editor: Steven Glaros Associate Editor: Stephen Brooks, ELS Production Manager: Liz Haberkorn Manuscripts Coordinator: Karen Darley Permissions / Reprint Coordinator: Michele Tillson Advertising Manager: Julie Hilgenberg Director of Publications: Lois Douthitt

APTA Executive Staff Senior Vice President for Communications: Felicity Feather Clancy Chief Financial Officer: Rob Batarla Chief Executive Officer: John D. Barnes

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Editor in Chief

Rebecca L. Craik, PT, PhD, FAPTA, Philadelphia, PA [email protected]

Deputy Editor in Chief

Daniel L. Riddle, PT, PhD, FAPTA, Richmond, VA

Editor in Chief Emeritus

Jules M. Rothstein, PT, PhD, FAPTA (1947–2005)

Steering Committee

Anthony Delitto, PT, PhD, FAPTA (Chair), Pittsburgh, PA; J. Haxby Abbott, PhD, MScPT, DipGrad, FNZCP, Dunedin, New Zealand; Joanell Bohmert, PT, MS, Mahtomedi, MN; Alan M. Jette, PT, PhD, FAPTA, Boston, MA; Charles Magistro, PT, FAPTA, Claremont, CA; Ruth B. Purtilo, PT, PhD, FAPTA, Boston, MA; Julie Whitman, PT, DSc, OCS, Westminster, CO

Editorial Board

Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP, Malvern, Victoria, Australia; W. Todd Cade, PT, PhD, St. Louis, MO; James Carey, PT, PhD, Minneapolis, MN; John Childs, PT, PhD, Schertz, TX; Charles Ciccone, PT, PhD, FAPTA (Continuing Education), Ithaca, NY; Joshua Cleland, PT, DPT, PhD, OCS, FAAOMPT, Concord, NH; Janice J. Eng, PT/OT, PhD, Vancouver, BC, Canada; James C. (Cole) Galloway, PT, PhD, Newark, DE; Steven Z. George, PT, PhD, Gainesville, FL; Kathleen Gill-Body, PT, DPT, NCS, Boston, MA; Paul J.M. Helders, PT, PhD, PCS, Utrecht, The Netherlands; Maura D. Iversen, PT, ScD, MPH, Boston, MA; Diane U. Jette, PT, DSc, Burlington, VT; Christopher Maher, PT, PhD, Lidcombe, NSW, Australia; Christopher J. Main, PhD, FBPsS, Keele, United Kingdom; Kathleen Kline Mangione, PT, PhD, GCS, Philadelphia, PA; Patricia Ohtake, PT, PhD, Buffalo, NY; Carolynn Patten, PT, PhD, Gainesville, FL; Linda Resnik, PT, PhD, OCS, Providence, RI; Kathleen Sluka, PT, PhD, Iowa City, IA; Patty Solomon, PT, PhD, Hamilton, Ont, Canada

Statistical Consultants

Ad Marketing Group, Inc 2200 Wilson Blvd, Suite 102-333 Arlington, VA 22201 703/243-9046, ext 102

Steven E. Hanna, PhD, Hamilton, Ont, Canada; John E. Hewett, PhD, Columbia, MO; Hang Lee, PhD, Boston, MA; Xiangrong Kong, PhD, Baltimore, MD; Paul Stratford, PT, MSc, Hamilton, Ont, Canada; Samuel Wu, PhD, Gainesville, FL

President / Advertising Account Manager: Jane Dees Richardson

Committee on Health Policy and Ethics

Board of Directors President: R. Scott Ward, PT, PhD Vice President: Paul A. Rockar Jr, PT, DPT, MS Secretary: Babette S. Sanders, PT, MS Treasurer: Connie D. Hauser, PT, DPT, ATC Speaker of the House: Shawne E. Soper, PT, DPT, MBA Vice Speaker of the House: Laurita M. Hack, PT, DPT, MBA, PhD, FAPTA Directors: Sharon L. Dunn, PT, PhD, OCS; Kevin L. Hulsey, PT, DPT, MA; Dianne V. Jewell, PT, DPT, PhD, CCS, FAACVPR; Aimee B. Klein, PT, DPT, DSc, OCS; Kathleen K. Mairella, PT, DPT, MA; Stephen C.F. McDavitt, PT, DPT, MS, FAAOMPT; Lisa K. Saladin, PT, PhD; Mary C. Sinnott, PT, DPT, MEd; Nicole L. Stout, PT, MPT, CLT-LANA

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Linda Resnik, PT, PhD, OCS (Chair), Providence, RI; Janet Freburger, PT, PhD, Chapel Hill, NC; Alan Jette, PT, PhD, FAPTA, Boston, MA; Michael Johnson, PT, PhD, OCS, Philadelphia, PA; Justin Moore, PT, DPT, Alexandria, VA; Ruth Purtilo, PT, PhD, FAPTA, Boston, MA

Linking Evidence and Practice Advisory Group

Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP, Malvern, Victoria, Australia (Co-Chair); Diane U. Jette, PT, DSc, Burlington, VT (Co-Chair); W. Todd Cade, PT, PhD, St. Louis, MO; Christopher Maher, PT, PhD, Lidcombe, NSW, Australia; Kathleen Kline Mangione, PT, PhD, GCS, Philadelphia, PA; David Scalzitti, PT, DPT, PhD, Alexandria, VA

The Bottom Line Committee

Eric Robertson, PT, DPT, OCS; Joanell Bohmert, PT, MS; Lara Boyd, PT, PhD; James Cavanaugh IV, PT, PhD, NCS; Todd Davenport, PT, DPT, OCS; Ann Dennison, PT, DPT, OCS; William Egan, PT, DPT, OCS; Helen Host, PT, PhD; Evan Johnson, PT, DPT, MS, OCS, MTC; M. Kathleen Kelly, PT, PhD; Catherine Lang, PT, PhD; Tara Jo Manal, PT, MPT, OCS, SCS; Kristin Parlman, PT, DPT, NCS; Susan Perry, PT, DPT, NCS; Maj Nicole H. Raney, PT, DSc, OCS, FAAOMPT; Rick Ritter, PT; Kathleen Rockefeller, PT, MPH, ScD; Michael Ross, PT, DHS, OCS; Katherine Sullivan, PT, PhD; Mary Thigpen, PT, PhD; Jamie Tomlinson, PT, MS; Brian Tovin, DPT, MMSc, SCS, ATC, FAAOMPT; Nancy White, PT, MS, OCS; Julie Whitman, PT, DSc, OCS

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Subscriptions

Physical Therapy (PTJ) (ISSN 00319023) is published monthly by the American Physical Therapy Association (APTA), 1111 North Fairfax Street, Alexandria, VA 22314-1488, at an annual subscription rate of $12 for members, included in dues. Nonmember rates are as follows: Individual (inside USA)— $99; individual (outside USA)—$119 surface mail, $179 air mail. Institutional (inside USA)—$129; institutional (outside USA)—$149 surface mail, $209 air mail. Periodical postage is paid at Alexandria, VA, and at additional mailing offices. Postmaster: Send address changes to Physical Therapy, 1111 North Fairfax Street, Alexandria, VA 22314-1488. Single copies: $15 USA, $15 outside USA; with the exception of January 2001: $50 USA, $70 outside USA. All orders payable in US currency. No replacements for nonreceipt after a 3-month period has elapsed. Canada Post International Publications Mail Product Sales Agreement No. 0055832.

Members and Subscribers Send changes of address to: APTA, Attn: Membership Dept, 1111 North Fairfax St, Alexandria, VA 22314-1488. Subscription inquiries: 703/684-2782, ext 3124. PTJ is available in a special format for readers who are visually impaired. For information, contact APTA’s Membership Department at 703/684-2782, ext 3124.

Mission Statement

Physical Therapy (PTJ) engages and inspires an international readership on topics related to physical therapy. As the leading international journal for research in physical therapy and related fields, PTJ publishes innovative and highly relevant content for both clinicians and scientists and uses a variety of interactive approaches to communicate that content, with the expressed purpose of improving patient care.

Readers are invited to submit manuscripts to PTJ. PTJ’s content—including editorials, commentaries, letters, and book reviews—represents the opinions of the authors and should not be attributed to PTJ or its Editorial Board. Content does not reflect the official policy of APTA or the institution with which the author is affiliated, unless expressly stated.

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Full-text articles are available for free at ptjournal.apta.org 12 months after the publication date. Full text also is provided through DataStar, Dialog, EBSCOHost Academic Search, Factiva, InfoTrac, ProFound, and ProQuest.

Reprints

PTJ Online at www.ptjournal.org

Readers should direct requests for reprints to the corresponding author of the article. Students and other academic customers may receive permission to reprint copyrighted material from this publication by contacting the Copyright Clearance Center Inc, 222 Rosewood Dr, Danvers, MA 01923. Authors who want reprints should contact June Billman, Cadmus Communications, at 800/4875625, or [email protected]. Nonacademic institutions needing reprint permission information should go to ptjournal.apta.org/misc/terms.dtl.

PTJ Online is available via RSS feeds. PTJ posts articles ahead of print and rapid reader responses to articles. Articles, letters to the editor, and editorials are available in full text starting with Volume 79 (1999) and in searchable PDF format starting with Volume 60 (1980). Entire issues are available online beginning with Volume 86 (2006) and include additional data, video clips, and podcasts.

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PTJ is indexed and/or abstracted by Abridged Index Medicus, Abstracts of Health Care Management Studies, AgeLine, Allied and Complementary Medicine Database (AMED), Bibliography of Developmental Medicine and Child Neurology, Current Contents, Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE/Exerpta Medica, Exceptional Child Education Resources, Focus on: Sports Science and Medicine, General Science Index (GSI), Health Index, Hospital and Health Administration Index, Index Medicus, Inpharma Weekly, International Nursing Index, ISR, Medical & Surgical Dermatology, MEDLINE, Neuroscience Citation Index, Personal Alert: Automatic Subject Citation Alert (ASCA), Pharmacoeconomics and Outcomes News, Physical Education Index, Reactions Weekly, RECAL Bibliographic Database, Science Citation Index (SCI), Social Sciences Citation Index (SSCI), and SportsS. Article abstracts are available online at ptjournal.apta.org (1980 through present) and via DataStar, Dialog, FirstSearch, Information Access, Ovid

January 2010

Technologies. Ingenta provides online document delivery for articles published since September 1988.

Advertisements are accepted by PTJ when they conform to the ethical standards of the American Physical Therapy Association. PTJ does not verify the accuracy of claims made in advertisements, and acceptance does not imply endorsement by PTJ or the Association. Acceptance of advertisements for professional development courses addressing advanced-level competencies in clinical specialty areas does not imply review or endorsement by the American Board of Physical Therapy Specialties.

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Editorial PTJ Helps Clinicians Link Evidence to Patient Care

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ave you ever had a patient with an unusual problem—or a typical problem that presents in an unusual way? Do patients ever ask you questions about an intervention based on information that they googled on the Internet? Do your students ask questions about the effectiveness of one treatment approach over another? If you’ve answered yes to one or more of these questions, you might have found yourself wishing that you better understood how to find and interpret evidence about the usefulness of one intervention compared to another or about the value of a particular diagnostic finding in determining the best plan of care. As a practitioner, you have to make many clinical decisions in the course of a day, often without adequate time or access to the best evidence. And even when some evidence is available, there are many factors that can affect clinical decisions, such as patient circumstances and preferences and clinician experience and education.1 What do you do when there is uncertainty about the optimal management of a patient? You might resolve to do a quick search of the literature before the patient returns for the next visit, but good searches take time, something you don’t have. Or maybe you are able to carve out time for a search and actually turn up a seemingly useful study—only to find that it doesn’t apply very well to your patient after all or that the conclusions were equivocal anyway. In a survey of physical therapists published in 2003, the majority agreed that using evidence in practice was necessary and that use of evidence improved the quality of patient care and decision making.2 At the same time, they identified insufficient time as one of the top 3 barriers to using evidence in their practice. Because evidence is cumulative—and because it is rare for a single study, no matter how well it’s conducted, to provide definitive evidence—certainty in clinical decision making may be impossible. So, one approach for the busy clinician is to rely on the results of systematic reviews to inform daily practice. Well-conducted systematic reviews critically examine and summarize the available body of evidence, usually randomized clinical trials, to identify benefits and harms of specific interventions. Other systematic reviews may identify optimal prognostic strategies or provide prognostic estimates for various disorders. By synthesizing results of individual studies, systematic reviews can save the clinician time in searching and reading individual studies, and, because systematic reviews include an assessment of the risk of bias of individual studies, they also can help the clinician judge the validity of research findings.

To comment, submit a Rapid Response to this editorial posted online at www.ptjournal.org.

Systematic reviews are, in themselves, scientific studies. They start with a clinical question; apply a detailed, methodical, and reproducible search of all available literature; and use specific criteria for selection of studies related to the question. In this way, bias is minimized. Selected studies are then critically appraised to determine the quality of their methods, and, in the case of clinical trials, a pooled estimate of the treatment benefit (and harms) may be ascertained, with an indication of the overall strength of the evidence. Systematic reviews can provide implications for clinical practice; however, in many instances, the varying level of both quality and generalizability of the studies in the review precludes definitive recommendations for practice. This is particularly frustrating for clinicians who


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Editorial may be unsure about how best to then use the information in their clinical decision making. Furthermore, treatment decisions for individual patients often require a weighing of the risks and benefits of many possible treatment choices, the preferences of the patient, and the feasibility of the interventions in a particular setting. And that’s why we’re launching Linking Evidence and Practice (page 9). This new series will offer real-life clinical scenarios, provide relevant information from Cochrane systematic reviews and other sources, and discuss the use of this evidence in practice. The Cochrane Collaboration is an international not-for-profit organization that aims to help health care providers, patients, and policy makers make well-informed decisions on health care treatments by synthesizing, maintaining, and disseminating high-quality systematic reviews.3 The collaboration includes 52 Cochrane review groups that comprise people from around the world who share an interest in developing and maintaining systematic reviews relevant to a particular health area. For example, the Cochrane Musculoskeletal Group (CMSG), one of the largest Cochrane review groups, has more than 600 active researchers, health care professionals, and consumer representatives from 26 countries (including 10 developing nations) who conduct and disseminate research on musculoskeletal conditions.4 Cochrane reviews are well known for a rigorous and systematic approach to collecting and appraising evidence, and many advances in the provision of health care have come from the efforts of Cochrane Collaboration members.* The goal of is to provide clinicians with best available evidence for various conditions in a format that is designed to streamline the application of evidence to practice. Over the coming year we will present a variety of clinical cases along with a synthesis of best available evidence for each case. Emphasis usually will be on interventions, but vignettes also may be designed with a focus on diagnosis or prognosis. The primary emphasis with all cases will be to summarize evidence in a way that is clear and accessible. We look forward to your feedback and your suggestions on how this new feature can enhance your care provision of care. Contact us at [email protected].

APTA members have access to the Cochrane Database of Systematic Reviews via Open Door at www.apta. org/OpenDoor.

Diane U. Jette, PT, DSc Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP Editorial Board Members References 1 Jette DU, Jette AM. Professional uncertainty and treatment choices by physical therapists. Arch Phys Med Rehabil. 1997;78:3146–3151. 2 Jette DU, Bacon K, Batty C, et al. Evidence-based practice: beliefs, attitudes, knowledge, and behaviors of physical therapists. Phys Ther. 2003;83:786–805. 3 Cochrane Collaboration. Available at: http://www.cochrane.org/docs/descrip.htm. Accessed November 17, 2009. 4 Buchbinder R, Tugwell P, Busch A, et al. Cochrane Musculoskeletal Group. Available at: http://www.mrw. interscience.wiley.com/cochrane/clabout/articles/MUSKEL/frame.html. [DOI: 10.2522/ptj.2010.90.1.6]

*

A recently updated Cochrane Handbook for Systematic Reviews of Interventions describes in detail the process of creating Cochrane systematic reviews and lists the new methodological guidelines. The Cochrane Library (http://www3.interscience.wiley.com/cgi-bin/mrwhome/106568753/HOME) contains both completed systematic reviews and outlines of those that are proposed and in preparation. The Library can be accessed for free in many countries (in the United States, however, only the state of Wyoming offers free access through public libraries).

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LINKING EVIDENCE AND PRACTICE Pulmonary Rehabilitation Following Acute Exacerbation of Chronic Obstructive Pulmonary Disease Diane U. Jette, Mary C. Bourgeois, Rachelle Buchbinder highlights the findings and application of Cochrane reviews and other evidence pertinent to the practice of physical therapy. The Cochrane Library is a respected source of reliable evidence related to health care. Cochrane systematic reviews explore the evidence for and against the effectiveness and appropriateness of interventions— medications, surgery, education, nutrition, exercise—and the evidence for and against the use of diagnostic tests for specific conditions. Cochrane reviews are designed to facilitate the decisions of clinicians, patients, and others in health care by providing a careful review and interpretation of research studies published in the scientific literature.1 Each article in this new PTJ series will summarize a Cochrane review or other scientific evidence resource on a single topic and will present clinical scenarios based on real patients to illustrate how the results of the review can be used to directly inform clinical decisions. The first article in the series focuses on a patient with chronic obstructive pulmonary disease (COPD) who has had a recent exacerbation that required medical intervention. Should this patient undergo pulmonary rehabilitation?

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he American Thoracic Society defines COPD as “a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.”2 Prevalence of COPD in adults who are 40 years old or older is approximately 10%.3 Chronic obstructive pulmonary disease is a leading cause of death and disability,4 and acute exacerbation is one of the main causes of hospitalization and death.5 An exacerbation of COPD is defined as “an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough, and/or sputum, that is beyond normal day-to-day variations, is acute in onset and may warrant a change in medication in a patient with underlying COPD.”6(p xiv) Pulmonary rehabilitation has been shown to be effective in improving exercise capacity, physical function, and quality of life and in reducing dyspnea and fatigue in people with COPD.7 Pulmonary rehabilitation takes many forms but usually includes, at a minimum, exercise training and patient education. Other interventions may include smoking cessation strategies, ventilatory muscle training, airway clearance techniques, medication management, and psychological support. Because

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the studies included in a 2006 Cochrane systematic review only had participants without recent COPD exacerbations,7 Puhan et al8 conducted an additional Cochrane review of randomized clinical trials to determine the effect of pulmonary rehabilitation on patients with recent COPD exacerbations requiring inpatient or outpatient care. In the review, the pulmonary rehabilitation intervention had to include at least some form of exercise training beginning within 3 weeks of the COPD exacerbation. The primary outcome of interest was subsequent hospital admissions. Secondary outcomes also were examined, such as mortality, quality of life, and exercise capacity. The results of the review are outlined in the Table.

Take-Home Message The Cochrane review by Puhan et al8 indicates that pulmonary rehabilitation is effective in reducing the chance of hospitalization and mortality following an acute exacerbation of COPD. Pulmonary rehabilitation following acute COPD exacerbation also results in improvements in health-related quality of life and exercise capacity. Adverse effects of pulmonary rehabilitation following an acute exacerbation of COPD were not found in the review. Because pulmonary rehabilitation programs commonly focus on educating the patient to make such lifestyle changes as increasing physical activity, reducing smoking, and seeking care for early signs of upper respiratory infections, an advantage of pulmonary


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Case #1 Pulmonary Rehabilitation Following Acute Exacerbation of COPD Table.

Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD): Cochrane Review Results8 ➢ Six randomized controlled trials were included in the review, with a total of 241 participants recruited following an acute exacerbation of COPD. ➢ The average ages of the participants in the included studies were between 62 and 70 years, and the average disease severity, as measured by forced expiratory volume in 1 second (FEV1), was between 36% and 40% of predicted level. ➢ Exercise program mode, duration, and frequency varied across studies. ➢ Studies compared patients receiving pulmonary rehabilitation that included at least physical exercise with patients who had conventional community care. ➢ Overall, outcomes favored the pulmonary rehabilitation intervention group. Hospitalizations

Across 3 studies, 57 people out of 100 in the control group had hospital admission over 34 weeks, compared with 14 out of 100 for the pulmonary rehabilitation group.

Mortality

Across 3 studies, 29 people out of 100 in the control group died over a mean of 107 weeks, compared with 10 out of 100 for the pulmonary rehabilitation group.

Health-related quality of life

Chronic Respiratory Disease Questionnaire9 scores favored the pulmonary rehabilitation group over the conventional therapy group in all domains (dyspnea, fatigue, emotional function, and mastery) in the 2 studies measuring this outcome (1.15 units to 1.88 units difference). Minimal important difference is 0.5 on 7-point scales.10 St George’s Respiratory Questionnaire11 scores favored the pulmonary rehabilitation group over the conventional therapy group in 2 of the 4 domains (activity limitation and impact) in the studies measuring this outcome (−9.9 units and −17.1 units difference). Minimal important difference is 4 units on 100-point scales.12

Exercise capacity

Six-minute walk13 distance favored the pulmonary rehabilitation group over the conventional therapy group in the 4 studies measuring this outcome (mean difference of 107 m). An important effect is ≥35 m.14 Shuttle-Walking test15 score favored the pulmonary rehabilitation group over the conventional therapy group in the 2 studies measuring this outcome (mean difference of 81 m). The minimal clinically important difference is 47.5 m.16

Adverse events

Two trials reported no adverse events. Four trials did not include statements of adverse event.

rehabilitation following acute exacerbation of COPD may be related to patients’ improved readiness to change following the distress of an acute episode. In addition, patients who participate in a pulmonary rehabilitation program have continuity of care in terms of reinforcing proper use of medication and attention to important symptoms. A potential disadvantage of participating in a pulmonary rehabilitation program following an acute exacerbation of COPD is that patients may have severely reduced endurance, necessitating a slower progression of exercise and a longer rehabilitation process to gain clinically important improvements. An understanding of the relative benefits and limitations of pulmonary rehabilitation after an acute exacerbation of COPD is useful when making 10 ■ Physical Therapy Volume 90 Number 1


clinical decisions with individual patients.

Case #1: Applying Evidence to a Patient With COPD Can pulmonary rehabilitation help this patient? Ms Wilson is a 64-year-old woman with a 10-year history of COPD who had a series of 3 COPD exacerbations over a 4-month period. These exacerbations required medical intervention with antibiotic treatment and oral steroids, but she was never hospitalized. Following the third exacerbation, Ms Wilson complained of moderate exertional dyspnea and was unable to perform her usual exercise program at home. Her forced expiratory volume in 1 secJanuary 2010

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Case #1 Pulmonary Rehabilitation Following Acute Exacerbation of COPD ond (FEV1) was 35% of predicted level. Ms Wilson’s impairments included reduced exercise capacity with a 6-minute walk distance of 385 m (predicted=497 m17), impaired ventilation with an inability to properly pace breathing during activity, reduced lower-extremity muscle strength, and impaired gas exchange with desaturation to 86% on 3 L/min of supplemental oxygen during activity. Completion of the Chronic Respiratory Disease Questionnaire (CRQ) yielded the following scores: dyspnea=13/35, fatigue=18/28, emotional function=35/49, and mastery=17/28. Ms Wilson’s goals were to improve activity tolerance, avoid further COPD exacerbations, maintain oxygen saturation above 90%, and return to work. How did the results of the Cochrane systematic review apply to Ms Wilson? Based on evidence from the systematic review described in this article, Ms Wilson, her physician, and her physical therapist agreed that she would be a good candidate for an outpatient pulmonary rehabilitation program. Ms Wilson began an outpatient pulmonary rehabilitation consisting of 2-hour supervised group sessions twice per week. The program included endurance training and strength-

ening and flexibility exercises over an 18-week period. Stair climbing with instruction in paced breathing strategies was incorporated gradually. Ms Wilson completed all exercises with 3 L/min of supplemental oxygen. How well do the outcomes of the intervention provided to Ms Wilson match those suggested by the systematic review? By the end of the 18-week period, 6-minute walk distance had increased to 442 m. The CRQ score improvements included: dyspnea=20/35, fatigue=20/28, emotional function=38/49, and mastery=22/28. In addition, all muscle groups demonstrated strength improvements. Ms Wilson met her goals of returning to part-time work and restarting her home walking program. She had no hospitalizations. Can you apply the results of the systematic review to your own patients? The findings of this review apply well to patients with acute exacerbations of COPD. The review criteria allowed studies with patients requiring inpatient or outpatient care; however, the review found only studies in which participants had been hospitalized for their exacerbations, and Ms Wilson had not been hospitalized to manage her exacerbations. The health care team still considered that it was reasonable to extrapolate the findings from the review to Ms Wilson’s case. She was otherwise similar to trial participants, and there were no compelling reasons to expect

that the results would not be generalizable to patients who have exacerbations managed out of the hospital. What can be advised based on the results of this systematic review? Patients fitting the description of the participants as outlined in the Table are likely to benefit from an inpatient, outpatient, or homebased pulmonary rehabilitation program that includes endurance exercise training, strengthening exercises, and education. Similar to participants in the included studies and Ms Wilson, people engaging in a pulmonary rehabilitation program following acute exacerbation are likely to show clinically meaningful improvements in health-related quality of life and exercise capacity. Finally, patients engaging in pulmonary rehabilitation may reduce their chances for future hospitalizations and odds of death over a period of 3 months to 4 years. D.U. Jette, PT, DSc, is Professor and Chair, Department of Rehabilitation and Movement Science, University of Vermont, Burlington, Vermont. M.C. Bourgeois, PT, DPT, CCS, is Clinical Assistant Professor, Department of Physical Therapy, MGH Institute of Health Professions, Boston, Massachusetts. R. Buchbinder, PhD, is Professor, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.

References 1

2

3

The Cochrane Library. Available at: http:// www3.interscience.wiley.com/cgi-bin/ mrwhome/106568753/HOME. Accessed December 8, 2009. COPD Guidelines, Definitions. Available at: http://www.thoracic.org/sections/ copd/for-health-professionals/definitiondiagnosis-and-staging/definitions.html. Accessed October 15, 2009. Halbert RJ, Natoli JL, Gano A, et al. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006;28:523–532.

©2009, Juice Images Ltd. All rights reserved.

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Case #1 Pulmonary Rehabilitation Following Acute Exacerbation of COPD 4 5

6

7

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Calverley PMA, Walker P. Chronic obstructive pulmonary disease. Lancet. 2003;362(9389):1053–1061. Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest. 2002;121(5 Suppl):121S–126S. Global Initative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Lung Disease: Medical Communication Resources Inc; 2009. Available at: http:// www.goldcopd.com/Guidelineitem. asp?l1=2&l2=1&intId=2003. Accessed December 2009. Lacasse Y, Goldstein R, Lasserson TJ, Martin S. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2006(4):CD003793. Puhan M, Scharplatz MA, Troosters T, et al. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2009(3):CD005305.

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Guyatt G, Berman L, Townsend M, et al. A measure of quality of life for clinical trials in chronic lung disease. Thorax. 1987;42:773–778. Schünemann HJ, Puhan M, Goldstein R, et al. Measurement properties and interpretability of the Chronic Respiratory Disease Questionnaire (CRQ). COPD. 2005;2:81–89. Jones PW, Quirk FH, Baveystock CM. The St. George’s respiratory questionnaire. Respir Med. 1991;85(suppl B):25– 31. Schünemann HJ, Griffith L, Jaeschke RZ, et al. Evaluation of the minimal important difference for the feeling thermometer and the St. George’s Respiratory Questionnaire in patients with chronic airflow obstruction. J Clin Epidemiol. 2003;56:1170–1176. Butland RJA, Pang J, Gross ER, et al. Two-, six-, and twelve-minute walking tests in respiratory disease. Br Med J. 1982;284:1607–1608.

14 Puhan MA, Mador MJ, Held U, et al. Interpretation of treatment changes in six-minute walk distance in patients with COPD. Eur Respir J. 2008;32:637– 643. 15 Singh SJ, Morgan MD, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992;47:1019–1024. 16 Singh SJ, Jones PW, Evans R, Morgan MDL. Minimum clinically important improvement for the incremental shuttle walking test. Thorax. 2008;63:775– 777. 17 Enright PL, Sherril DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998;158:1384–1387. [DOI: 10.2522/ptj.2010.90.1.9]

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Research Report Exposure to Low Amounts of Ultrasound Energy Does Not Improve Soft Tissue Shoulder Pathology: A Systematic Review Lisa D. Alexander, David R.D. Gilman, Derek R. Brown, Janet L. Brown, Pamela E. Houghton L.D. Alexander, MPT, is a medical student at the University of Toronto. D.R.D. Gilman, MPT, is Physiotherapist, Grand River Physiotherapy, Fergus, Ontario, Canada. D.R. Brown, MPT, is Physiotherapist, Rehab Health Inc, Brantford General Hospital, Brantford, Ontario, Canada. J.L. Brown, HBAPE, BScPT, MEd, is Lecturer, School of Physical Therapy, University of Western Ontario, London, Ontario, Canada. P.E. Houghton, HBSc, BScPT, PhD, is Associate Professor, School of Physical Therapy, University of Western Ontario, Room 1458, Elborn College, London, Ontario, Canada N6G 1H1. Address all correspondence to Dr Houghton at: [email protected]. [Alexander LD, Gilman DRD, Brown DR, et al. Exposure to low amounts of ultrasound energy does not improve soft tissue shoulder pathology: a systematic review. Phys Ther. 2010;90:14 –25.] © 2010 American Physical Therapy Association

Background. Although therapeutic ultrasound is commonly used to treat shoulder injuries, research to date on the ability of ultrasound to improve outcomes for shoulder pathologies is conflicting. Objective. This study aimed to systematically and critically review available literature to ascertain whether beneficial effects of ultrasound were associated with certain shoulder pathologies or particular ultrasound treatment protocols.

Methods. Five electronic databases were searched, and the included studies, identified through pair consensus, were randomized controlled trials (RCTs) that utilized ultrasound for soft tissue shoulder injury or pain.

Study Selection and Data Extraction. Eight studies included in this review (n⫽586 patients, median PEDro score⫽8.0/10) evaluated various parameters, including the duration of patients’ symptoms (0 –12 months), duty cycle (20% and 100%), intensity (0.1–2.0 W/cm2), treatment time per session (4.5–15.8 minutes), number of treatments (6 –39), and total energy applied per treatment (181– 8,152 J).

Data Synthesis. Inconsistent outcome measures among studies precluded metaanalysis; however, 3 RCTs showed statistically significant benefits of ultrasound, 2 of which examined calcific tendinitis. Studies that showed beneficial effects of ultrasound typically had 4 times longer total exposure times and applied much greater ultrasound energy per session (average of 4,228 J) compared with studies that showed no benefit of ultrasound (average of 2,019 J). No studies that delivered ⱕ720 J per session showed improvement in treatment groups. Limitations. Current research involving ultrasound treatment protocols that delivered low levels of ultrasound energy do not adequately address whether ultrasound can improve outcomes for shoulder disorders. Conclusion. Determining whether therapeutic ultrasound can affect soft tissue shoulder pathologies will require further research and systematic reviews that involve appropriate ultrasound treatment protocols.

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houlder pain constitutes approximately 16% of all musculoskeletal complaints,1 making it the third most common musculoskeletal disorder, next only to low back and neck disorders.2 The annual incidence of 15 new episodes of shoulder pain per 1,000 patients seen in the primary care setting3 may peak during the fourth and fifth decades of life.4 The symptoms of new episodes of shoulder pain in the primary care setting have been shown to persist for at least 1 year in 40% to 50% of patients.5,6 Shoulder pain with associated soft tissue pathology can be divided into several diagnostic categories, including subacromial impingement syndrome, tendinitis, tendinosis, bursitis, calcific deposits, and myofascial tears. The causes of such disorders can be multifactorial7 and may be associated with repetitive movements and overuse, trauma, surgical intervention, thoracic kyphosis, advancing age, acromioclavicular or glenohumeral osteophytes, decreased mobility in the cervicothoracic spine, autoimmune and inflammatory diseases, or metabolic diseases.7–11 The human shoulder complex provides a stable, yet mobile, base of support upon which coordinated movements can occur; this requirement of diametrically opposed functions also may be an underlying etiology of shoulder dysfunction. The aims of conservative treatments for shoulder complaints are to identify and ameliorate the underlying

Available With This Article at ptjournal.apta.org • Audio Abstracts Podcast This article was published ahead of print on November 12, 2009, at ptjournal.apta.org.

January 2010

etiology, when possible, and to control symptoms such as pain. Conservative treatments include, but are not limited to, analgesics, nonsteroidal anti-inflammatory drugs, steroid injections, and physical therapy; the last may include therapeutic exercise, joint mobilization and manipulation, education, and the application of physical modalities such as ultrasound.12,13 Ultrasound is widely used in the management of soft tissue injuries.14 –18 Seven systematic reviews and metaanalyses previously examined the effectiveness of ultrasound for musculoskeletal disorders.6,13,17–21 In 4 of these studies,6,13,20,21 1 of which was a Cochrane review,13 investigators reported on a wide range of physical therapy interventions for the treatment of shoulder pain or disorders. The 3 remaining reviews17–19 included studies in which only the effects of ultrasound treatment were examined but in which participants exhibited a wide range of musculoskeletal disorders (eg, chronic wounds, myofascial pain, osteoarthritis) affecting several body locations (eg, perineum, ankle, low back). In a 1999 review of the treatment of shoulder disorders, van der Heijden concluded that “there was sufficient evidence that physical modalities, including ultrasound, do not contribute to pain reduction or recovery from shoulder disorders.”6(p303) The Philadelphia Panel clinical practice guidelines on interventions for shoulder pain20 concluded that ultrasound is beneficial in the treatment of calcific tendinitis but that it has not been shown to be clinically important for nonspecific shoulder complaints, such as bursitis and tendinitis. For the most part, these conclusions are in agreement with the findings of the 2003 Cochrane review.13 However, the fact that these reviews included such a wide range of treatment interventions and heterogeneous patient populations

could have masked any specific indication for ultrasound treatment. In addition, no published review has included newer studies (published since 1999) examining the effects of ultrasound on shoulder disorders. A more focused review specifically examining the effects of ultrasound on soft tissue disorders of the shoulder is warranted. Furthermore, in published articles in which the clinical evidence for the ultrasound treatment of shoulder pathologies was reviewed, the appropriateness and rigor of the ultrasound treatment protocols used in the clinical trials were not considered. In a 2001 review of ultrasound effectiveness studies, Robertson and Baker17 were the first to calculate and compare the total amounts of ultrasound energy delivered to tissues to examine the effects of ultrasound dosages on study outcomes. However, included in that review were clinical trials involving many musculoskeletal conditions (eg, chronic wounds, carpal tunnel syndrome, osteoarthritis of the knee). Accordingly, the studies included in that review involved a wide range of ultrasound treatment protocols because many different conditions and body locations were treated with ultrasound. To calculate the ultrasound energy delivered, the authors also had to make several assumptions about transducer head size and treatment area, a fact that they suggested “was clearly a potential source of error in subsequent calculations.”17(p1345) Therefore, given the heterogeneity and limitations of previous systematic reviews, there is a need to systematically review and critically evaluate existing literature to specifically examine the potential effects of ultrasound treatment of soft tissue disorders of the shoulder. The purposes of this study were to identify relevant randomized clinical trials

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Ultrasound for Soft Tissue Shoulder Pathology (RCTs) and to evaluate ultrasound treatment protocols to determine whether certain ultrasound treatment parameters were associated with improvements in soft tissue shoulder impairments or function. The specific study protocol characteristics that were evaluated in this review included the clinical characteristics of the study populations (eg, type of pathology treated, time since symptom onset) and the ultrasound parameters (eg, duty cycle, frequency, treatment time per session, total exposure, total ultrasound energy applied both per session and over the entire duration of each study).

Table 1.

Method

Table 2.

Data Sources A search of 5 electronic databases (CINAHL, 1982–2008; Cochrane Central Register of Controlled Trials, 1947–2008; EMBASE, 1947–2008; MEDLINE, 1950 –2008; and PubMed, 1950 –2008) was conducted and limited by language (English), population (humans), and study type (RCT). The search included investigations published in print or electronically before April 2008. The search terms used for this process are listed in Table 1. Before the literature search was conducted, specific study inclusion and exclusion criteria were formulated (Tab. 2). To be included in the current investigation, studies had to exhibit an RCT design that involved patients who were 18 years of age or older and who exhibited soft tissue shoulder pathology or pain not attributable to hemiparesis, systemic rheumatic or autoimmune conditions, fractures, osteoarthritis, or surgical interventions. Included studies also had to report ultrasound treatment protocols in sufficient detail to enable us to calculate the power and total ultrasound energy delivered (see calculations in “Data Extraction” section below).

Study Inclusion and Exclusion Criteria

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Search Terms Used to Identify Potentially Relevant Studies Part

Search Terms

A

Ultrasound OR physical therapy OR physiotherapy OR rehabilitation OR pulsed ultrasound OR ultrasonic therapy OR continuous ultrasound OR therapeutic ultrasound OR sonic therapy OR high-frequency sound waves OR MHz OR kHz OR sound wave OR cavitation OR acoustic microstreaming

B

Shoulder tendonitis OR shoulder tendinitis OR shoulder tendinopathy OR shoulder tendinosis OR shoulder strain OR rotator cuff pathology OR rotator cuff tear OR rotator cuff injury OR rotator cuff strain OR rotator cuff tendonitis OR rotator cuff tendinitis OR rotator cuff tendinosis OR shoulder bursitis OR subdeltoid bursitis OR subacromial bursitis OR rotator cuff impingement OR supraspinatus impingement OR shoulder impingement OR calcific tendonitis OR calcific tendinitis OR acromioclavicular sprain OR coracoclavicular sprain OR rotator cuff rupture OR frozen shoulder OR adhesive capsulitis OR biceps tendonitis OR biceps tendinitis OR biceps tendinosis OR bicipital tendonitis OR bicipital tendinitis OR bicipital tendinopathy OR infraspinatus tear OR supraspinatus tear OR infraspinatus tendonitis OR infraspinatus tendinitis OR infraspinatus tendinosis OR infraspinatus tendinopathy OR bicipital strain OR biceps strain OR supraspinatus strain OR infraspinatus strain

Parameter Population

Inclusion Criteria

Exclusion Criteria

Age ⱖ18 y

Fracture

Acute or chronic condition

Dislocation

Soft tissue shoulder injury

Neurological involvement

Shoulder pain (not directly attributed to conditions listed under “exclusion criteria”)

Systemic rheumatic or autoimmune conditions (eg, multiple sclerosis, rheumatoid arthritis) Osteoarthritis Surgery Trigger points

Intervention

Therapeutic ultrasound

Diagnostic ultrasound

Pulsed or continuous ultrasound

Inability to calculate spatial average–temporal average or total energy Iontophoresis

Study design

Randomized controlled trial (RCT)

Review, meta-analysis, case study, non-RCT

Outcome measures

Pain scale

Examiner’s impression of change

Muscle strength (force-generating capacity) testing Range of motion Function, impairment, or disability measures

Study Selection Primary search part A: selection of relevant titles and abstracts. Initially, for identification of studies that met inclusion criteria, each database was searched independently by at least 2 authors of the present

Number 1

study. In part A of the search, the titles and abstracts (citations) of all studies identified in the electronic database search were assessed. For a study to be included for further assessment (part B: review of full article), a pair consensus regarding inJanuary 2010

Ultrasound for Soft Tissue Shoulder Pathology clusion was reached. In instances of doubt about whether to include a study for further assessment, the full article was retrieved. Primary search part B: identification of full articles. Full articles were obtained from the citations identified in part A of the electronic database search. Two copies of each article were randomly distributed among 3 researchers, who independently reviewed each article and determined whether the study met the inclusion criteria. Secondary search. For further identification of potentially relevant studies, a secondary search was performed. In this stage of the investigation, the authors examined the reference lists of the relevant publications, such as reviews, metaanalyses, and case studies. Any relevant articles were retrieved and assessed for inclusion independently by 2 reviewers. These articles were selected by use of the pair consensus process described above. Quality Assessment (Critical Appraisal) For each study selected for inclusion from the primary search or the secondary search, 3 reviewers independently conducted Physiotherapy Evidence Database (PEDro) assessments. The PEDro scale was chosen for this critical appraisal process because it can allow for a reliable assessment of the RCT design quality.22 No study was excluded on the basis of methodological quality. The PEDro scale ranges from 0 to 10, with 10 indicating the best possible score. Data Extraction The results of included studies were extracted and analyzed. From the extracted data, the spatial average–temporal average (SATA, W/cm2), energy density per treatment (J/cm2), total energy delivered during a single January 2010

treatment (J), and total exposure to ultrasound over the entire duration of the study (hours) were calculated. These parameters were determined with the following equations: SATA (W/cm2) ⫽

(1)

average intensity (W/ cm2) ⫻ duty cycle 共%兲共2兲

Energy density per treatment (J/cm2) ⫽ SATA (W/cm2) ⫻ time per treatment (seconds)

共3兲

Total energy per treatment (J) ⫽ SATA (W/cm2) ⫻ transducer head size or

effective radiating area (cm2) ⫻ time per treatment (seconds) Total exposure (hours) ⫽

(4)

number of treatments ⫻ time per treatment (seconds) (5)

Total energy delivered

over entire study duration (J) ⫽ total energy per treatment (J) ⫻ number of treatments

Results As indicated in the Figure, the electronic database search yielded 727 results, with the following number of citations for each database: CINAHL (127), Cochrane Central Register of Controlled Trials (38), EMBASE (464), MEDLINE (18), and PubMed (80). Thirty full articles were identified from the search of these citations, and 697 articles were excluded. An additional 11 articles were identified from the secondary search of references cited in book chapters, reviews, and other articles. Through a pair consensus process, 33 of the 41 selected articles were excluded on the basis of the prede-

termined criteria. Eight original RCTs examining the effects of ultrasound on shoulder pathology were included in the present report.23–30 A total of 586 participants were enrolled in the 8 included studies, with 543 participants following through to completion. In 3 of the 8 studies included in the present systematic review, Shomoto et al,23 Ebenbichler et al,24 and Downing and Weinstein27 reported that ultrasound produced outcomes significantly better than those seen in control groups. In 2 of these studies, the impact of ultrasound on calcific tendinitis was specifically examined, and both Shomoto et al23 and Ebenbichler et al24 found significant reductions in pain and calcium deposits. Ebenbichler et al24 also found significant improvements in function. Assessment of the RCT design quality of the 8 included studies yielded a median PEDro scale score of 8.0 (range⫽4 –10) (Tab. 3). The following shoulder pathologies were examined in the included studies: calcific tendinitis, shoulder pain, subacromial bursitis, adhesive capsulitis, biceps tendinitis, and supraspinatus tendinitis (Tab. 4). The duration of participants’ symptoms before enrollment varied between and within the studies, ranging from 0 to greater than 12 months, with the majority of studies involving chronic shoulder disorders (ie, ⬎6 weeks since symptom onset). There was a tendency for investigators to use multiple concurrent treatments within each study; although some used only 1 concurrent treatment,24,29 others used multiple concurrent treatments, including heat, interferential current (IFC), range-of-motion exercises, and strengthening.23,25–28,30 Concurrent therapies offered to participants treated with ultrasound and control participants within a study were similar; however, none of the 8

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Figure. Flow diagram of search strategy and summary of excluded studies. PEDro⫽Physiotherapy Evidence Database, RCT⫽randomized controlled trial.

studies involved the same concurrent treatment regimens. In 2 of the studies, IFC was applied in addition to ultrasound.25,28 The results reported in 1 such study28 suggested that similar reductions in shoulder impairments occurred over time in subjects treated with ultrasound and subjects treated with IFC and that no additional benefit was observed when IFC and ultrasound were combined.

studies, a scale ranging from 0 to 3 was used (1 study rated pain during a specific resisted movement,26 another rated pain during rest and movement,25 and the third rated Table 3.

Physiotherapy Evidence Database (PEDro) Scale Scores of Included Studies

A wide array of outcome measures also were used across the studies. Several different outcome measures were used to assess quality of life, pain, and functional ability. In the 7 studies in which pain was reported as an outcome, little overlap in the measures used was observed: In 3 18

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pain during daily activities27); in the remaining 4 studies, a 10-point numeric rating scale,24 a 10-point visual analog scale,30 a 7-point Likert scale,28 or a dichotomous scale

Number 1

Study Shomoto et al

PEDro Scale Score

(2002)23

4

Ebenbichler et al (1999)24 Kurtais Gu¨rsel et al

(2004)25

Nykanen (1995)26 Downing and Weinstein

9 7 7

(1986)27

van der Heijden et al (1999)28

10 10

(1960)29

4

Ainsworth et al (2007)30

9

Median score

8.0

Roman

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1.0

NR

0 to ⬎12 mo

⬎2 mo

Bursitis

Shoulder pain

Supraspinatus tendinosis

Roman (1960)29

van der Heijden et al (1999)28

Nykanen (1995)26

1 or 3

1.5 3.0

7b 4b

6.7c 0.5

1.0

1.5

5b

5

1.2

10

2.5

1.0–2.0

4.3b

5

Average Intensity (W/cm2)

Head Size or ERA (cm2)

Pulsed (20)

Pulsed (20)

Pulsed (20)

Continuous

Continuous

Continuous

Pulsed (20)

Continuous

Duty Cycle (%)

0.13

0.2

0.6

1.5

1.5

1.2

0.5

1.0–2.0

SATA (W/cm2)

4.5

10

5

5–8

10

6

15.0

15.8

Rx Time/ Session (min)

181

600

720

3,150–5,040

4,500

4,320

2,250

4,076–8,152

Total Energy/ Rx (J)

6

10–12

12

8.24

15

12

24

28–39

Average No. of Rxs

Therapeutic Ultrasound Treatment Parameters

0.45

1.67–2.0

1.0

0.6–1.1

2.5

1.2

6.0

7.4–10.3

Total Exposure (h)

1,085

6,000

8,640

25,956–41,529

67,500

51,840

54,000

114,128–317,928

Total Energy Over Study Duration (J)

Advice, manual therapy, exercise (home)

Heat, massage, exercise (stretching, strengthening)

NSAID, IFC, exercise (ROM, strengthening)

Heat (20 min)

Heat, IFC, exercise (ROM, stretching, strengthening)

NSAID, exercise (ROM)

Analgesics

Mobilization, exercise (stretching, strengthening)

Concurrent Treatments

No

No

No

...

No

No

Yes

Yes

Pain

...

...

...

No

...

...

Yes

Yes

Ca

...

...

No

No

No

Yes

...

...

ROM

Outcomes

No

No

No

...

No

No

Yes

...

Fn/Dis

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Total ultrasound energy delivered over study duration (J) ⫽ ultrasound energy per treatment ⫻ number of treatments

The ERA was reported. c Head size was estimated as the average value for the area used in the other 7 studies.

b

Energy per Rx (J) ⫽ SATA (W/cm2) ⫻ head size or ERA (cm2) ⫻ Rx time (s)

Total exposure (h) ⫽ number of treatments ⫻ treatment time

SATA ⫽ average intensity (W/cm2) ⫻ duty cycle

a Table is arranged in order of total ultrasound energy delivered per session. Chronicity⫽duration of participants’ symptoms before study enrollment, ERA⫽effective radiating area, SATA⫽spatial average– temporal average, Rx⫽treatment, Pain⫽statistically significant pain reduction compared with outcome in control group, Ca⫽calcium deposit reduction, ROM⫽improved range of motion, Fn/Dis⫽functional improvement or reduction in disability, ellipsis⫽not assessed, NSAID⫽nonsteroidal anti-inflammatory drug, NR⫽not reported, IFC⫽interferential current. Equations were as follows:

NR

0.87

NR

Rotator cuff tendinitis or partial rupture; biceps tendinosis

Kurtais Gu¨rsel et al (2004)25

Shoulder pain

1.0

⬍1 y

Supraspinatus tendinitis; adhesive capsulitis; subacromial bursitis

Downing and Weinstein (1986)27

Ainsworth et al (2007)30

0.89

⬎4 wk

Calcific tendinitis

Ebenbichler et al (1999)24

1.0

3.0

Frequency (MHz)

⬎3 mo

Chronicity

Calcific tendinitis

Pathologies Treated

Shomoto et al (2002)23

Study

Summary of Included Studiesa

Table 4.


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Ultrasound for Soft Tissue Shoulder Pathology Table 5. Comparison of Studies in Which Ultrasound Was Reported to Be Beneficial and Studies in Which No Statistical Difference Was Found Between Treatment and Control Groups Ultrasound Found Beneficial

Parameter No. of studies Total no. of participants Energy density, J/cm2, X៮ (range)a Total energy per session, J, X៮ (range)a

3

5

121

465

768 (432–1,422)

413 (27–900)

4,228 (2,250–6,114)

2,019 (181–4,095)

5.3 (1.2–10.3)

1.3 (0.5–2.5)

Total exposure, h, X៮ (range)a Total energy over study duration, J, X៮ (range)a

Ultrasound Found Equivalent to Control

107,289 (51,840–216,028)

20,394 (1,085–67,500)

a Values for studies in which a benefit of ultrasound was seen or in which no benefit was seen in the ultrasound group compared with the control group. Studies were considered “beneficial” when a statistically significant improvement in 1 or more of the chosen outcome measures was reported. Equations were as follows:

Energy density ⫽ spatial average – temporal average ⫻ treatment time Total energy per session ⫽ spatial average – temporal average ⫻ transducer head size ⫻ treatment time Total exposure ⫽ treatment time per session ⫻ number of sessions Total energy over study duration ⫽ total energy per session ⫻ number of sessions The treatment area sizes were considered to be the same for all of the studies because only the shoulder area was included in these studies.

(“yes” or “no”) was used.23 Quantitative outcome measures used included x-ray imaging for calcific deposits23,24 and goniometric measures of shoulder range of motion.25,27,30 Because of the wide range of outcome measures and the variety of treatment parameters used in the studies, pooling results for a metaanalysis was not possible in the present investigation. The intensity of ultrasound used varied greatly among the studies, as SATA values ranged from 0.1 to 2.0 W/cm2. In 4 of the 8 studies included in the present review, pulsed ultrasound was used (20% duty cycle),24,26,28,30 and in the other 4 studies, continuous ultrasound waves were used.23,25,27,29 The mean application time per treatment session and the number of treatment sessions were also variable, ranging from 4.5 to 15.8 minutes per treatment session and from 6 to 39 treatment sessions. The transducer head size or effective radiating area was 20

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reported in all but 1 study (Ainsworth et al30), and in most studies, similar head sizes were used (4 –5 cm2). The ultrasound machine used in the study by Downing and Weinstein27 was larger (10 cm2). The total energy delivered per session was calculated to be greater than 2,250 J in most of the studies,23–25,27,29 but it was much lower in the studies of Nykanen,26 van der Heijden et al,28 and Ainsworth et al.30 The total exposure times varied greatly among the studies, ranging from 0.45 to 10.3 hours. Calculations of the total ultrasound energy delivered over the entire duration of each study (total energy ⫻ number of treatment sessions) demonstrated the dramatic differences in the amounts of ultrasound energy to which subjects in the different studies were exposed (Tab. 4). In particular, in the recently published study of Ainsworth et al,30 the total energy delivered per session was 181 J. This low level of ultrasound energy, com-

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bined with the relatively small number of treatments administered (6 treatments), resulted in a total exposure over the study duration (1,085.4 J) that was about 1/100 of the average for the studies that were included in the present review and that noted a benefit of ultrasound (107,289 J) (Tab. 5). Calculations performed to compare and contrast the intensity and duration of ultrasound exposure in the 3 studies in which a benefit of ultrasound treatment was reported with those in studies in which no significant difference between participants receiving ultrasound treatment and control participants was reported are provided in Table 5. Average values for the ultrasound energy density, the total ultrasound energy delivered per session, and the amount of time ultrasound was applied over the entire study duration were all at least 2 times higher in studies that detected a significant improvement in subjects treated with ultrasound versus control subjects than in studies that failed to find a difference between those groups of subjects. Participants in studies in which ultrasound was not found to be beneficial received an average level of ultrasound energy for the study duration that was one fifth of that in studies in which ultrasound was found to be beneficial (Tab. 5). Unfortunately, there were fewer studies with fewer participants in which effective ultrasound treatment protocols were used.

Discussion The present systematic review of the available research on ultrasound as it relates to the treatment of soft tissue shoulder disorders and pain resulted in a total of 8 RCTs that met the inclusion criteria. Three of the 8 trials revealed statistically significant improvements in outcomes for treated participants compared with control participants. Studies that deJanuary 2010

Ultrasound for Soft Tissue Shoulder Pathology tected statistically significant improvements in patients treated with ultrasound generally involved higher levels of total ultrasound energy per treatment and provided longer exposure times than studies that failed to detect a difference between patients treated with ultrasound and control patients. Studies in which a benefit of ultrasound (relative to placebo ultrasound) was reported tended to include subjects from a well-defined patient population (such as those with calcific tendinitis). Along with identifying study protocol characteristics that have been associated with more beneficial results for ultrasound in the management of shoulder injuries, this investigation also sought to identify attributes in currently available RCTs that may have obfuscated previous assessments of the effectiveness of ultrasound in treating shoulder complaints. These issues are outlined below. Classification of Shoulder Pathology All of the studies included in the present review focused on soft tissue musculoskeletal disorders of the shoulder. Specific inclusion and exclusion criteria were applied consistently, and potential subjects were excluded if their shoulder disorders involved neurological or systemic inflammatory conditions. In 6 of the 8 included studies,23–28 subjects underwent a screening evaluation performed by an independent assessor, and diagnostic imaging was used to confirm the diagnosis in 3 of the studies.23–25 In 2 of the 8 included studies, subjects had a wide range of conditions, such as rotator cuff tendinitis and tendinosis, biceps tendinitis, subacromial bursitis, and adhesive capsulitis, in the same study populations.25,27 These disorders have been shown to vary greatly with respect to the underlying cellular processes and pathologies at January 2010

work,31–35 thereby reducing the likelihood of achieving a valid conclusion concerning the effectiveness of ultrasound. Likewise, in 2 of the 8 studies, subjects had shoulder disorders broadly categorized as causing “shoulder pain.”28,30 As indicated by Burbank et al,7 who outlined standardized diagnostic criteria for numerous categories of shoulder disorders, the diagnosis of shoulder pain falls well short of the mark for the degree of diagnostic precision that clinicians can achieve by obtaining a focused medical history and performing a careful physical examination. By categorizing study participants in this nonspecific manner, investigators risk obtaining a highly heterogeneous study population for which it could be difficult to avoid type 2 errors. Furthermore, by broadly categorizing study participants as experiencing shoulder pain, investigators risk including people who are experiencing referred pain from the cervical spine or other regions of the body and who, in fact, do not have true shoulder pathology. It is clear that in future studies of the effectiveness of ultrasound, every effort should be made to assemble a highly homogeneous study population. This goal can be greatly facilitated with the aid of diagnostic imaging. Several imaging modalities, such as radiography, ultrasonography, and magnetic resonance imaging, can be of substantial diagnostic value for conditions such as osteoarthritis, rotator cuff pathology (eg, tendinopathy, full- or partialthickness tears), and calcific tendinitis.7 The benefit of using imaging modalities to help define a focused study population may be evident in the studies (described in the present investigation) that included only participants with calcific tendinitis. In both of these trials, ultrasound (relative to placebo ultrasound) was reported to result in significant improvements.

Staging or Chronicity of Shoulder Disorders Previous RCTs examining the effects of therapeutic ultrasound on shoulder disorders also may have had a limited ability to detect changes because they included participants with a broad range of symptom durations (chronicity of the condition). Three of the 8 investigations included in the present study did not explicitly report the chronicity of participants’ conditions.25,29,30 In the remaining 5 studies,23,24,26 –28 patients’ pre-enrollment symptom durations ranged from 0 to greater than 12 months. Combining acute, possibly first-occurrence shoulder disorders with chronic, possibly recurrent disorders in a study population may be especially problematic given that the duration of patients’ symptoms has been shown to dictate the pathological state of affected tissues. For example, histopathological studies have revealed striking differences among the 3 well-documented stages of adhesive capsulitis34,36 and between acute and chronic tendinopathy31,33,37,38 (tendinitis versus tendinosis). Because acute tendinopathy has been characterized by the presence of inflammatory mediators,31 whereas chronic tendinopathy involves a disorganized collagen structure and changes consistent with hypoxia,39 it is unlikely that these disparate pathologies would respond in similar ways to a uniform set of ultrasound parameters. In fact, it is more likely that, given the differences in the proposed effects of nonthermal ultrasound and thermal ultrasound, a pulsed duty cycle and a continuous duty cycle would be most beneficial for acute and chronic injuries, respectively. Thus, the broad range in chronicity exhibited by participants within many studies, combined with the facts that all participants within a given study received the same treatment protocols and that acute and

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Ultrasound for Soft Tissue Shoulder Pathology chronic injuries were not necessarily treated with the potentially most appropriate duty cycle, may account partly for the relatively small amount of evidence supporting the utility of therapeutic ultrasound for soft tissue shoulder pathology. Future investigations need to account for the fact that the same ultrasound protocols cannot be used to treat conditions with vastly different underlying pathophysiological processes. Multiple Concurrent Treatments Unfortunately, of the 8 studies identified in the present analysis, none included a similar treatment program in the control arm of the study. Thus, it appears that there is little agreement about the standard treatment approach for soft tissue disorders of the shoulder. In 6 of the 8 studies,23,25–28,30 exercise was part of the treatment intervention; however, the type and intensity of these programs were not provided in any detail to allow an assessment for similarities. Ebenbichler et al24 used the fewest cointerventions, allowing occasional use of analgesics (but not anti-inflammatory medications) as required in both study groups. In contrast, Kurtais Gu ¨ rsel et al25 provided up to 6 concurrent treatments. Although it may be a common clinical practice to combine different types of therapies, such as exercise, medications, and modalities, to address shoulder pathologies, it is not clear why the authors elected to administer several similar concurrent modalities (such as heat, ultrasound, and IFC). This approach seems to be unjustified and very likely may have masked any potential effect of the ultrasound treatment protocol because the proposed physiological effects of ultrasound may be similar to those induced by the concurrent treatments. Although the authors did ensure that the cointerventions were similar between the comparison groups, we strongly recommend that future clinical trials testing the ther22

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apeutic benefits of ultrasound avoid the use of concurrent modalities or treatments with effects that are similar to or counterproductive to the suggested physiological effects of ultrasound. Study Design and Size of Study Population Assessment with the PEDro scale suggested that, on average, the included studies had most of the desirable methodological attributes (such as internal validity and statistical rigor) that are evaluated with this scale. The average PEDro scale score assigned by our 3 independent evaluators was 8.0, which was in keeping with the scores assigned to these clinical trials by the Centre for Evidence Based Physiotherapy (average score⫽6.75).40 We did not elect to remove any study on the basis of the PEDro scale score, partly because of contention regarding whether investigators are actually able to use effective masking strategies for ultrasound.17 A common feature of more recent RCTs is the use of prestudy calculations to establish the sample size required to detect the desired or presumed effect size of treatment. When effect sizes are thought to be relatively small, larger sample sizes are required to detect the differences between 2 groups. It is worth noting that only 1 of the 8 studies included in the present analysis conducted such calculations to ensure that an adequate sample size was used. Ainsworth et al30 suggested that a sample size of at least 200 patients was required to detect a meaningful change in their primary outcome measure (the Shoulder Disability Questionnaire). A much smaller sample size requirement of 26 participants for ultrasound studies was suggested in a review by Robertson and Baker.17 Four of the studies23,25,27,29 included in the present review failed to meet this (n⫽26) suggested sam-

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ple size. Therefore, it is possible that studies involving very small numbers of subjects25,29 may not have detected differences between groups because of reduced statistical power. Similarly, small sample sizes may partly explain the positive findings reported by Downing and Weinstein27 and Shomoto et al.23 Notably, the 2 studies involving the largest sample sizes28,30 did not find a significant difference in outcome measures between subjects treated with ultrasound and control subjects, suggesting that the inability to find a difference between the groups was not necessarily attributable to inadequate sample sizes. Future studies of therapeutic ultrasound for shoulder injuries should include sample size calculations and demonstrate that a sufficient number of participants were included to detect differences between study groups. Given the inherent difficulties with recruiting a large homogeneous population of subjects into any particular study, problems with inadequate sample size may be addressed more easily by combining results from several studies with a meta-analysis; however, this method would require a more consistent use of valid outcome measures that are known to be able to accurately assess shoulder impairments and upper-extremity function. Ultrasound Stimulus Parameters and Treatment Protocols Experimental human research studies have demonstrated that the physiological responses to ultrasound depend on ultrasound intensity and frequency. Draper and colleagues41,42 showed that the average rates of temperature increase per minute with continuous ultrasound administered at a frequency of 1 MHz were 0.04°C at 0.5 W/cm2, 0.16°C at 1.0 W/cm2, 0.33°C at 1.5 W/cm2, and 0.38°C at 2.0 W/cm2. Also, the rates of temperature inJanuary 2010

Ultrasound for Soft Tissue Shoulder Pathology crease per minute with ultrasound at a higher frequency (3 MHz) were 0.3°C at 0.5 W/cm2, 0.58°C at 1.0 W/cm2, 0.8°C at 1.5 W/cm2, and 1.4°C at 2.0 W/cm2. Although changes in tissue temperatures (thermal responses) are only part of the biological responses produced by the mechanical waves of ultrasound, these measurable changes strongly support the assertion that the amount of ultrasound energy delivered to tissues depends on the ultrasound parameters selected. Given the barely detectable temperature change occurring when lowfrequency (1-MHz) ultrasound was delivered at an intensity of 0.5 W/cm2, it is very unlikely that the ultrasound treatment used by Ainsworth et al30 would have achieved sufficient levels of the desired physiological responses to induce changes in their primary outcome measures of pain and range of motion. The low ultrasound intensity used in that study was confounded by the use of the pulsed ultrasound mode (20% duty cycle), the application of short treatments (4.5 minutes), and the limited number of treatment sessions. Collectively, these factors made the total amount of ultrasound energy delivered in that study one fifth of the average amount used in the other included studies. These arguably suboptimal ultrasound treatment parameters must be considered a key determinant that may explain the lack of effect observed in the study of Ainsworth et al.30 Of concern is the fact that the study of Ainsworth et al30 is the most recent report in the literature that has examined the effectiveness of ultrasound for soft tissue shoulder disorders. That study was a multisite investigation performed in 9 centers in the United Kingdom with 221 study participants. The ultrasound treatment regimen was not defined by the study protocol but rather by the January 2010

average ultrasound treatment parameters selected by the 28 physical therapists applying the treatments. The average ultrasound intensity was 0.5 W/cm2 (range⫽0.1–1.0 W/cm2) applied for 4.5 minutes (range⫽3–7 minutes), with 46% and 39% of therapists selecting 1 MHz and 3 MHz, respectively. These results suggest that common practice in this region of the United Kingdom is to apply ultrasound treatments that deliver extremely little sound energy to the target tissues. Of greater concern is that the practice of applying relatively low intensities of pulsed ultrasound for relatively short periods of time (5 minutes or less) is apparently being adopted more broadly across the profession of physical therapy. Although current evidence to support the use of ultrasound in the treatment of shoulder pathologies is limited, there is good evidence to suggest that the application of suboptimal ultrasound parameters like those used by Ainsworth et al30 is extremely unlikely to provide additional benefits to patients with soft tissue shoulder disorders. Calculations of total ultrasound energy revealed 2- to 5-fold-larger amounts of ultrasound energy per treatment and longer exposure times (treatment time ⫻ number of treatments) in studies in which a benefit of ultrasound was reported. Furthermore, none of the studies in which ⱕ720 J per session was applied reported an additional benefit of ultrasound. We feel that studies delivering such low doses of ultrasound energy are in effect delivering sham ultrasound and could not reasonably be expected to produce treatment effects.

Conclusions The findings of the present study reveal that favorable patient outcomes in RCTs of therapeutic ultrasound for shoulder pain and injury have been noted when ultrasound energy

of at least 2,250 J per treatment session was applied. Furthermore, when insufficient ultrasound energy (ie, ⱕ720 J per session) was provided, positive outcomes rarely occurred. Our results suggest that the effectiveness of ultrasound on soft tissue pathologies has not yet been evaluated using optimal treatment parameters, and, therefore, it is premature to conclude through systematic review of existing literature that this treatment dose “is not effective.”6,13,18 However, systematic reviews conducted to date6,13,18 have focused their evaluation of study quality on generic aspects of study design such as studies’ randomization processes, blinding, and statistical analyses. Our findings echo the general concerns reported by Robertson and Baker17 and agree with the criticisms of others43– 45 that the prohibitive conclusions of previous systematic reviews in this realm are based on weak evidence. More recent trials28,30 that used improved RCT designs with larger sample sizes have used ultrasound treatment protocols that resulted in the delivery of 1/5 to 1/20 of the average ultrasound energy per session that was used in ultrasound studies that produced beneficial results. Should these RCTs that used suboptimal ultrasound treatment protocols be included in future systematic reviews, the question of the effectiveness of ultrasound treatment for these common musculoskeletal disorders will remain an uncertainty for many years to come.

Future Directions Future primary studies must focus on selecting optimal ultrasound treatment parameters that deliver more than 720 J of ultrasound energy per session (perhaps closer to an average of 4,228 J per session) and treatment schedules that expose tissues to ultrasound for a sufficient period of time (ie, average total exposure time

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Ultrasound for Soft Tissue Shoulder Pathology of ⬎5 hours). Providing sufficient detail in future reports, such as including descriptions of the transducer head size and treatment area, is required if ultrasound treatment protocols are to be critically evaluated. Such studies must also create more homogeneous treatment groups with respect to the diagnosis and chronicity of the disorder. Future investigators should be cognizant of the histopathological state of affected target tissues before selecting the ultrasound parameters that will be used in an investigation to determine whether the thermal or nonthermal effects of ultrasound will likely be of most benefit (see Xu and Murrell,33 Sharma and Maffulli,37 and Khan et al38 for excellent reviews of tendinopathy histopathology). Although there may be ethical reasons why all concurrent therapies cannot be withheld, eliminating the application of similar modalities during a clinical trial may help to unmask some of the benefits of adding ultrasound to the treatment of patients with shoulder pathology. Standardizing the outcome measures used between studies and maintaining consistent characteristics of application are needed if studies with relatively small sample sizes are to be combined by use of meta-analytical techniques. In addition, it is critically important to this area of practice that researchers involved in future systematic reviews or meta-analyses strongly consider the appropriateness of ultrasound treatment parameters when selecting articles to be included in a review. In a recent article, Norman et al46 referred to the lessons of Cronbach and proposed that instead of examining the main effects of treatments, investigators should focus on identifying the characteristics of people that make them more or less responsive to particular treatments. Although this direction of research may not be the most scientifically 24

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rigorous, it does account for the facts that practitioners treat patients, not pathologies, and that patients may respond to their efforts in different ways. Thus, study designs other than RCTs, such as carefully designed case studies, may prove to be critical for determining which ultrasound parameters should be used for treating individual patients. All authors provided concept/idea/research design and writing. Ms Alexander, Mr Gilman, and Mr Brown provided data collection. Ms Alexander, Mr Gilman, Mr Brown, and Ms Brown provided data analysis. Dr Houghton provided project management. Ms Brown and Dr Houghton provided consultation (including review of manuscript before submission). This article was received September 4, 2008, and was accepted August 13, 2009. DOI: 10.2522/ptj.20080272

References 1 Urwin M, Symmons D, Allison T, et al. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998;57: 649 – 655. 2 Bridges-Webb CH, Britt D, Miles S, et al. Treatment in general practice in Australia. Med J Aust. 1992;156(suppl):S1–S56. 3 van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995;54:959 –964. 4 Allander E. Prevalence, incidence, and remission rates of some common rheumatic diseases or syndromes. Scand J Rheumatol. 1974;3:145–153. 5 Brox JI. Shoulder pain. Best Pract Res Clin Rheumatol. 2003;17:33–56. 6 van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Clin Rheumatol. 1999;13:287–309. 7 Burbank KM, Stevenson JH, Czarnecki GR, Dorfman J. Chronic shoulder pain, part I: evaluation and diagnosis. Am Fam Physician. 2008;77:453– 460. 8 Smith LL, Burnet SP, McNeil JD. Musculoskeletal manifestations of diabetes mellitus. Br J Sports Med. 2003;37:30 –35. 9 Cakir M, Samanci N, Balci N, Balci MK. Musculoskeletal manifestations in patients with thyroid disease. Clin Endocrinol (Oxf). 2003;59:162–167.

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10 Norlander S, Gustavsson BA, Lindell J, Nordgren B. Reduced mobility in the cervicothoracic motion segment: a risk factor for musculoskeletal neck-shoulder pain—a two-year prospective follow-up study. Scand J Rehabil Med. 1997;29:167–174. 11 Glockner SM. Shoulder pain: a diagnostic dilemma. Am Fam Physician. 1995;51: 1677–1687, 1690 –1692. 12 Burbank KM, Stevenson JH, Czarnecki GR, Dorfman J. Chronic shoulder pain, part III: treatment. Am Fam Physician. 2008;77: 493– 497. 13 Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;(2): CD004258. 14 Wong RA, Schumann B, Townsend R, Phelps CA. A survey of therapeutic ultrasound use by physical therapists who are orthopaedic certified specialists. Phys Ther. 2007;87:986 –994, discussion 995–1001. 15 Lindsay DM, Dearness J, McGinley CC. Electrotherapy usage trends in private physiotherapy practice in Alberta. Physiother Can. 1995;47:30 –34. 16 ter Haar G, Dyson M, Oakley EM. The use of ultrasound by physiotherapists in Britain, 1985. Ultrasound Med Biol. 1985;13: 659 – 663. 17 Robertson VJ, Baker KG. A review of therapeutic ultrasound: effectiveness studies. Phys Ther. 2001;81:1339 –1350. 18 van der Windt DA, van der Heijden GJ, van den Berg SG, et al. Ultrasound therapy for musculoskeletal disorders: a systematic review. Pain. 1999;81:257–271. 19 Gam AN, Johannsen F. Ultrasound therapy in musculoskeletal disorders: a meta-analysis. Pain. 1995;63:85–91. 20 Philadelphia Panel. Philadelphia Panel Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions for Shoulder Pain. Phys Ther. 2001; 81:1719 –1730. 21 van der Heijden GJ, van der Windt DA, de Winter AF. Physiotherapy for patients with soft tissue shoulder disorders: a systematic review of randomised clinical trials. BMJ. 1997;315:25–30. 22 Maher CG, Sherrington C, Herbert RD, et al. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther. 2003;83:713–721. 23 Shomoto K, Katsuhiko T, Morishita S, et al. Effects of ultrasound therapy on calcified tendinitis of the shoulder. Journal of the Japanese Physical Therapy Association. 2002;5:7–11. 24 Ebenbichler GR, Erdogmus CB, Resch KL, et al. Ultrasound therapy for calcific tendinitis of the shoulder. N Engl J Med. 1999; 340:1533–1538. 25 Kurtais Gu ¨ rsel Y, Ulus Y, Bilgiç A, et al. Adding ultrasound in the management of soft-tissue disorders of the shoulder: a randomized placebo-controlled trial. Phys Ther. 2004;84:336 –343.

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Ultrasound for Soft Tissue Shoulder Pathology 26 Nykanen M. Pulsed ultrasound treatment of the painful shoulder: a randomized, double-blind, placebo-controlled study. Scand J Rehabil Med. 1995;27:105–108. 27 Downing DS, Weinstein A. Ultrasound therapy of subacromial bursitis: a doubleblind trial. Phys Ther. 1986;66:194 –199. 28 van der Heijden GJ, Leffers P, Wolters PJ, et al. No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue shoulder disorders: a randomised controlled trial. Ann Rheum Dis. 1999;58:530 –540. 29 Roman MP. A clinical evaluation of ultrasound by use of a placebo technic. Phys Ther Rev. 1960;40:649 – 652. 30 Ainsworth R, Dziedzic K, Hiller L, et al. A prospective double blind placebocontrolled randomized trial of ultrasound in the physiotherapy treatment of shoulder pain. Rheumatology (Oxford). 2007; 46:815– 820. 31 Puddu G, Ippolito E, Postacchini F. A classification of Achilles tendon disease. Am J Sports Med. 1976;4:145–150. 32 Enwemeka CS. Inflammation, cellularity, and fibrillogenesis in regenerating tendon: implications for tendon rehabilitation. Phys Ther. 1989;69:816 – 825.

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33 Xu Y, Murrell GA. The basic science of tendinopathy. Clin Orthop Relat Res. 2008;466:1528 –1538. 34 Hand GC, Athanasou NA, Matthews T, Carr AJ. The pathology of frozen shoulder. J Bone Joint Surg Br. 2007;89:928 –932. 35 Hyvo ¨ nen P, Melkko J, Lehto VP, Jalovaara P. Involvement of the subacromial bursa in impingement syndrome of the shoulder as judged by expression of tenascin-C and histopathology. J Bone Joint Surg Br. 2003;85:299 –305. 36 Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005;331:1453–1456. 37 Sharma P, Maffulli N. Biology of tendon injury: healing, modeling and remodeling. J Musculoskelet Neuronal Interact. 2006; 6:181–190. 38 Khan KM, Cook JL, Bonar F, et al. Histopathology of common tendinopathies: update and implications for clinical management. Sports Med. 1999;27:393– 408. 39 Kannus P, Jozsa L. Histopathological changes preceding spontaneous rupture of a tendon: a controlled study of 891 patients. J Bone Joint Surg Am. 1991;73: 1507–1525. 40 Centre for Evidence Based Physiotherapy. www.cebp.nl. Accessed September 25, 2009.

41 Draper DO, Castel JC, Castel D. Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sports Phys Ther. 1995;22:142–150. 42 Draper DO, Ricard MD. Rate of temperature decay in human muscle following 3 MHz ultrasound: the stretching window revealed. J Athl Train. 1995;30:304 –307. 43 Draper DO. Don’t disregard ultrasound yet—the jury is still out [letter to the editor]. Phys Ther. 2002;82:190 –191. 44 Brockow T, Franke A, Resch KL. Physiotherapy for soft tissue shoulder disorders: conclusion that therapeutic ultrasound is ineffective was based on weak evidence [comment]. BMJ. 1998;316:555, author reply 556. 45 Amusat NT. On “A survey of therapeutic ultrasound . . .” Wong et al. Phys Ther. 2007;87:986 –994 [letter]. Phys Ther. 2007;87:1558 –1559, author reply 1559. 46 Norman GR, Stratford PW, Regehr G. Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. J Clin Epidemiol. 1997;50:869 – 879.

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Research Report P.E. Mintken, PT, DPT, OCS, FAAOMPT, is Assistant Professor, Department of Physical Therapy, School of Medicine, University of Colorado Denver, 13121 E 17th Ave, Mailstop C244, Aurora, CO 80045 (USA); and Lead Clinician, Wardenburg Health Center, University of Colorado at Boulder, Boulder, Colorado. Address all correspondence to Dr Mintken at: [email protected].

Some Factors Predict Successful Short-Term Outcomes in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation: A Single-Arm Trial

J.A. Cleland, PT, PhD, is Professor, Department of Physical Therapy, Franklin Pierce University, Concord, New Hampshire; Physical Therapist, Rehabilitation Services, Concord Hospital, Concord, New Hampshire; and Faculty, Manual Physical Therapy Fellowship Program, Regis University, Denver, Colorado.

Paul E. Mintken, Joshua A. Cleland, Kristin J. Carpenter, Melanie L. Bieniek, Mike Keirns, Julie M. Whitman

K.J. Carpenter, PT, DPT, is Physical Therapist, Waldron’s Peak Physical Therapy PC, Boulder, Colorado. Dr Carpenter was a student in the Department of Physical Therapy, School of Medicine, University of Colorado Denver, at the time of this study. M.L. Bieniek, PT, DPT, is Rehabilitation Manager and Physical Therapist, Concord Hospital. M. Keirns, PT, PhD, is Associate Professor, School of Physical Therapy, Regis University, and Clinical Director, Physiotherapy Associates, Greenwood Athletic Club, Greenwood Village, Colorado. J.M. Whitman, PT, DSc, is Director, Evidence In Motion’s Orthopedic Manual Physical Therapy Program, Louisville, Kentucky, and Assistant Professor, School of Physical Therapy, Regis University. [Mintken PE, Cleland JA, Carpenter KJ, et al. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010;90:26 – 42.] © 2010 American Physical Therapy Association

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Background. It has been reported that manipulative therapy directed at the cervical and thoracic spine may improve outcomes in patients with shoulder pain. To date, limited data are available to help physical therapists determine which patients with shoulder pain may experience changes in pain and disability following the application of these interventions. Objective. The purpose of this study was to identify prognostic factors from the history and physical examination in individuals with shoulder pain who are likely to experience rapid improvement in pain and disability following cervical and thoracic spine manipulation.

Design. This was a prospective single-arm trial. Setting. This study was conducted in outpatient physical therapy clinics. Participants. The participants were individuals who were seen by physical therapists for a primary complaint of shoulder pain. Intervention and Measurements. Participants underwent a standardized examination and then a series of thrust and nonthrust manipulations directed toward the cervicothoracic spine. Individuals were classified as having achieved a successful outcome at the second and third sessions based on their perceived recovery. Potential prognostic variables were entered into a stepwise logistic regression model to determine the most accurate set of variables for prediction of treatment success.

Results. Data for 80 individuals were included in the data analysis, of which 49 had a successful outcome. Five prognostic variables were retained in the final regression model. If 3 of the 5 variables were present, the chance of achieving a successful outcome improved from 61% to 89% (positive likelihood ratio⫽5.3).

Limitations. A prospective single-arm trial lacking a control group does not allow for inferences to be made regarding cause and effect. The statistical procedures used may result in “overfitting” of the model, which can result in low precision of the prediction accuracy, and the bivariate analysis may have resulted in the rejection of some important variables. Conclusions. The identified prognostic variables will allow clinicians to make an a priori identification of individuals with shoulder pain who are likely to experience short-term improvement with cervical and thoracic spine manipulation. Future studies are necessary to validate these findings.

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houlder pain can present a diagnostic challenge. One study on nonspecific shoulder pain showed rotator cuff tendinopathy in 85% of patients, but 77% were diagnosed with more than one shoulder problem.1 The most common causes of shoulder pain, namely rotator cuff pathology and adhesive capsulitis, may present similar findings but have a different set of outcomes and responses to specific treatments.2 Although specific diagnoses can be made in some patients with shoulder pain,3 de Winter et al4 reported only moderate agreement on the classification of shoulder disorders and concluded that differentiation among shoulder disorders is complicated. Dinant et al5 argued that we need a shift from diagnostic to prognostic research, as health care providers frequently see patients with conditions such as shoulder pain and low back pain that are difficult to accurately diagnose.

The prevalence of shoulder symptoms has been reported to range from 20% to 33%,6 and the incidence of shoulder complaints in the general population is increasing.7 Furthermore, several authors have reported low rates of perceived recovery for individuals with a new episode of shoulder pain.8 –11 The prognosis generally is poor, with re-

Available With This Article at ptjournal.apta.org • eTable 1: Categorical Variables From the Baseline Clinical Examination • eTable 2: Continuous Variables From the Baseline Clinical Examination • Audio Abstracts Podcast This article was published ahead of print on December 3, 2009, at ptjournal.apta.org.

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covery rates of only 49% to 59% at the time of an 18-month followup.9,11 Additionally, Rekola et al12 reported that 25% of individuals with shoulder or neck pain experienced at least one episode of recurrence within 12 months, suggesting that shoulder pain can be recurrent and frequently progresses to the chronic stage. This is important, as the direct costs for the treatment of people with shoulder dysfunction in the United States in 2000 totaled $7 billion.13 Furthermore, Kuijpers et al14 reported that patients with persistent shoulder pain generated 74% of the total costs. Regional interdependence is defined as “the concept that seemingly unrelated impairments in a remote anatomical region may contribute to, or be associated with, the patient’s primary complaint.”15(p658) This concept of examining and treating impairments away from the primary source of pain is gaining popularity in orthopedic manual therapy.15 Patients with primary reports of shoulder pain often have impairments of the shoulder girdle, including the cervicothoracic spine and the adjacent ribs, and these impairments can negatively affect patient outcomes.16 –21 For example, Sobel et al19 found that more than 40% of patients with shoulder complaints had impairments of the cervicothoracic spine and the adjacent ribs. They concluded that impairments in the cervicothoracic spine and adjoining ribs represent an integral part of the intrinsic causes of shoulder complaints. Additionally, Norlander and colleagues16 –18 investigated the correlation between mobility in the cervicothoracic junction in patients with musculoskeletal neck and shoulder pain and found a significant association between decreased mobility in the thoracic spine and the presence of patient-reported complaints associated with neck and shoulder pain. Impairments of the

cervicothoracic spine and adjacent ribs have been shown to predict a poor outcome and triple the risk for developing shoulder disorders.16 –19,22 Finally, Crosbie et al23 demonstrated in 32 women who were healthy that thoracic motion was present in both bilateral and unilateral shoulder elevation, and they concluded that a key link exists between the thoracic spine and arm elevation. Current evidence suggests that inclusion of manipulative interventions (both thrust and nonthrust techniques) indeed may be helpful in the treatment of individuals with shoulder pain.22,24 –27 Some studies have included cervicothoracic manipulative interventions in addition to other interventions in the management of shoulder pain.24 –26 To date, 2 studies have investigated the effectiveness of treatment directed solely at the cervicothoracic spine and ribs in individuals with shoulder pain.22,24 Boyles et al24 found that individuals with impingement syndrome who received thoracic spine thrust manipulation demonstrated significant improvements in pain and disability 48 hours after treatment. Bergman et al22 randomly assigned individuals with a primary report of shoulder pain to receive either usual medical care (UMC) for their shoulder symptoms from their primary care physicians or usual care plus manipulative therapy (UMC⫹MT) directed at the cervicothoracic spine and rib cage. Although there were no between-group differences identified at the 6-week follow-up, the UMC⫹MT group demonstrated significantly higher rates of “full recovery,” as well as more improvement in the severity of main complaints and disability at 12, 26, and 52 weeks.22 These findings suggest that a subgroup of individuals with shoulder pain may exist who will respond dramatically to these interventions.

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Recently, there have been multiple studies identifying prognostic variables to guide physical therapy interventions.28 –30 It would be useful for physical therapists to have guidance in selecting which patients with shoulder pain may experience improved outcomes following manipulative interventions targeted at the cervicothoracic spine. Thus, the purpose of this project was to identify prognostic factors for individuals with shoulder pain likely to experience improvements in pain and disability following the application of cervicothoracic spine thrust and nonthrust manipulation.

Materials and Method We conducted a prospective singlearm trial of consecutive individuals with a primary complaint of shoulder pain who were seen for physical therapy at 1 of 7 outpatient physical therapy clinics (Wardenburg Health Center, University of Colorado Boulder, Boulder, Colorado; the faculty practice at the University of Colorado Denver, Aurora, Colorado; Physiotherapy Associates, Greenwood Village, Colorado; Rehabilitation Services of Concord Hospital, Concord, New Hampshire; Groves Physical Therapy, St Paul, Minnesota; Newton Wellesley Hospital, Newton, Massachusetts; and Southwest Physical Therapy, Yuma, Arizona). Inclusion criteria required participants to be between the ages of 18 and 65 years, with a primary report of shoulder pain and a baseline Shoulder Pain and Disability Index (SPADI) score of 20% or greater. The SPADI is a self-administered questionnaire consisting of pain and disability subscales, where the means of the 2 subscales are combined to produce a total score ranging from 0 (best) to 100 (worst).31 The SPADI has excellent reliability, validity, and responsiveness.31,32 Exclusion criteria included any medical “red flags” suggestive of a nonmusculoskeletal etiology of symptoms, acute frac28

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tures in the shoulder region, acute severe trauma in the cervical or thoracic region in the previous 6 weeks, a diagnosis of cervical spinal stenosis or bilateral upper-extremity symptoms, osteoporosis, prior surgery to the cervical or thoracic region, evidence of central nervous system involvement, insufficient Englishlanguage skills to complete the questionnaires, or signs consistent with nerve root compression (defined as impairment in at least 2 of the following: myotomal strength, sensation, or reflexes). “Red flags” were ruled out by a combination of a medical screening questionnaire, a neurological examination, and a patient history.33 All participants reviewed and signed a consent form approved by one of the following institutional review boards: the University of Colorado at Boulder, Boulder, Colorado; the University of Colorado Denver, Denver, Colorado; Regis University, Denver, Colorado; Newton-Wellesley Hospital, Newton, Massachusetts; or Concord Hospital, Concord, New Hampshire. Physical Therapists Nine physical therapists participated in the examination and treatment of participants in this study. All therapists underwent a standardized training regimen, which included studying a manual of standard procedures with the operational definitions for each examination and treatment procedure used in this study. All participating therapists then underwent a 1-hour training session in which they practiced all study procedures to ensure they were performed in a standardized fashion. Participating therapists had a mean of 11.6 years (SD⫽10.2, range⫽0 –29) of clinical experience. Five of the 9 therapists were board certified in orthopedics and had received fellowship training in manual therapy.

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Examination Procedures Participants provided demographic information and completed a variety of standardized self-report measures,34 followed by a standardized history and physical examination at baseline. Self-report measures included a body diagram to assess the distribution of symptoms,35 a numeric pain rating scale (NPRS),36 the SPADI,31 the Modified FearAvoidance Beliefs Questionnaire (FABQ),37 and the Tampa Scale for Kinesiophobia (TSK). The body diagram was used to record the location and nature of a patient’s shoulder symptoms.38 The body diagram has been shown to be a reliable tool to localize a patient’s symptoms.39 The 11-point NPRS (range⫽0 –10) was used to measure pain intensity. The scale is anchored on the left with the phrase “no pain” and on the right with the phrase “worst imaginable pain.” The NPRS was used to rate the participants’ current level of pain and their worst and least amount of pain in the previous 24 hours. The average of the 3 ratings was used to represent each participant’s level of pain. Numeric pain scales have been shown to be reliable and valid.36,40,41 The FABQ is a 16-item questionnaire that was designed to quantify fear and avoidance beliefs in individuals with low back pain (LBP).37 The FABQ has 2 subscales: a 7-item scale to measure fear-avoidance beliefs about work and a 4-item scale to measure fear-avoidance beliefs about physical activity. Higher scores represent an increase in fear-avoidance beliefs. We modified the FABQ by changing the word “back” to “shoulder” on the questionnaire. We used the 11-item TSK that assesses fear of movement or of injury or reinjury.42 Individuals rate each item on a 4-point Likert scale, with scoring alternatives ranging from “strongly disagree” to “strongly agree.” TestJanuary 2010

Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation retest reliability is high.42 The SPADI is a 13-item questionnaire consisting of a pain domain with 5 questions and a disability domain with 8 questions. Each section is scored from 0% to 100%, with higher scores indicating higher levels of pain and disability. Beaton and Richards43 reported that the individual-level reliability of measurements obtained with the SPADI had an intraclass correlation coefficient of .91. The minimal clinically important difference (MCID) is 10 points. The historical examination included questions about age, sex, employment status, past medical history, expectations for treatment, mode of onset, location and nature of the patient’s symptoms, number of days since onset, aggravating and relieving factors, number of previous episodes of shoulder pain, and treatment for previous episodes. The physical examination began with a neurological screen,44 followed by an assessment of posture as described previously.28,45 GriegelMorris et al46 examined the reliability of postural assessment using a plumb line and reported a high degree of reliability (kappa⫽.83). The therapist then measured painfree active shoulder flexion47 and administered a battery of 3 functional tests described by Yang and Lin48: hand to neck, hand to scapula and hand to opposite shoulder movements. A soft tape measure was used to measure the resting position of the scapula from the midpoint of the sternal notch (SN) to the medial aspect of the coracoid process (CP) and the horizontal distance from the posterolateral angle of the acromion (PLA) to the thoracic spine (TS).49 The Scapula Index was calculated using the equation: [(SN to CP/PLA to TS) ⫻ 100].49 The lateral slide test was used to evaluate 3 different positions of the scapula as described by

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Kibler.50 Scapular dyskinesis was assessed as described by Kibler et al.51 The therapist then performed a battery of special pathoanatomic tests for the shoulder. These tests were selected based on their psychometric properties, including high sensitivity or specificity, identified during our literature review. As included participants had a primary complaint of shoulder pain, we wanted the tests to cover the spectrum of potential pathoanatomic conditions involving the shoulder. The tests included the load and shift test and the sulcus sign,52 the apprehension/relocation test,52 the Paxinos test and acromioclavicular joint palpation,53 the active compression test,54 the anterior slide test,55 the Hawkins-Kennedy impingement test,56 –58 the Neer impingement test,56 –58 the empty can and full can test,59 the drop sign,60 and the Speed test.61 Next, cervical range of motion (ROM) and symptom response were assessed using an inclinometer for flexion, extension, and side bending and a long-arm goniometer for rotation.62– 64 These measurements have been shown to have moderate intertester reliability.62,63,65 Active rotation of the thoracic spine was assessed visually, and any symptom provocation was recorded.65 We acknowledge that thoracic spine ROM is very difficult to measure accurately. The following tests were used to screen for cervical radiculopathy66: the Spurling test, the Upper Limb Tension Test, the distraction test, and cervical rotation active ROM. First rib mobility testing was performed in a sitting position67; the therapist palpated the first rib and assessed symmetry during quiet breathing and passive downward springing. The cervical rotation lateral flexion test also was performed in a sitting position.68

Passive ROM of the shoulder was measured as described by Norkin and White.69 Cross-chest adduction was measured in a supine position with the shoulder flexed to 90 degrees with 0 degrees of adduction to assess for posterior shoulder tightness.70 Passive accessory joint mobility as described by Maitland71 was assessed at the following joints: glenohumeral (anterior, posterior, and inferior glides, as well as distraction), acromioclavicular, and sternoclavicular. Based on comparison with the opposite shoulder, each motion was judged to be hypomobile, normal, or hypermobile. Finally, the therapist assessed the length72 and strength (forcegenerating capacity)45 of the muscles of the upper quarter and endurance of the deep neck flexor muscles.73 Spring testing of the cervical and thoracic spine (C2–T9) and ribs (1–9)74 and segmental mobility of the cervical spine72 were assessed for mobility and symptom response. Of the 80 participants who were enrolled in the study, 18 underwent a second examination by an additional therapist who was blind to the findings of the first clinician. The 18 participants who underwent a second evaluation were selected based on the availability of a second clinician to perform the examination. The reliability analysis was performed to evaluate the intertester reliability of data obtained for the identified potential prognostic variables. Treatment As treatment outcome served as the reference criterion,75 all participants received the same standardized treatment regardless of the results of the clinical examination. Treating clinicians were not permitted to adjust the intervention based on individual clinical decision-making processes.34 During each session, the participants received 1 nonthrust mobilization

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation technique directed at the lower cervical spine and 5 different thrust manipulation techniques directed at the thoracic spine. We used a large number of techniques targeting the cervical and thoracic regions, as it has been reported that patients with shoulder pain may have impairments from the cervicothoracic junction to the lower thoracic spine.16 –20,22,23,46,49 We wanted to be sure that we addressed any impairments that might be present in this region in order to maximize our chances for success. All techniques took less than 10 to 15 minutes to perform and are described below using the standardized terminology proposed by Mintken et al76: • A high-velocity, mid-range distraction force to the midthoracic spine on the lower thoracic spine in a sitting position (Appendix 1). • A low-velocity, end-range, left and right lateral translational force to the lower cervical spine on the upper thoracic spine in a supine position in “neutral” and slight cervical flexion (Appendix 1). • A high-velocity, end-range, anteriorposterior force through the elbows to the cervicothoracic junction on the upper thoracic spine in a supine position (Appendix 1). • A high-velocity, end-range, anteriorposterior force through the elbows to the upper thoracic spine on the midthoracic spine in a supine position in cervicothoracic flexion (Appendix 1). • A high-velocity, end-range, anteriorposterior force through the elbows to the middle thoracic spine on the lower thoracic spine in a supine position in cervicothoracic flexion (Appendix 1). • A high-velocity, mid-range, posteriorto-anterior force to the midthoracic spine on the upper thoracic spine in a prone position (Appendix 1).

Each nonthrust manipulation was performed for 30 seconds at each 30

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cervical level (C5–7) in neutral and slight cervical flexion (for a total of 6 bouts of oscillations to the left and 6 bouts of oscillations to the right). In order to maximize each patient’s opportunity for improvement, each individual received each thrust technique twice, for a total of 10 thrust manipulations per treatment session. Following the manual therapy interventions, all participants were instructed in 2 general spinal mobility exercises. The first was a general cervical mobility exercise called the “3finger ROM exercise” (Appendix 2).77 The second was a general thoracic mobility exercise performed in a supine position (Appendix 2).72 Individuals performed both exercises for 10 repetitions, 3 to 4 times per day, while participating in the study. Participants also received instruction to maintain their usual activity level within the limits of pain. The first treatment session always was performed on the day of the initial examination, and the participant was scheduled for a follow-up visit within 2 to 4 days. The 15-point Global Rating of Change (GROC) described by Jaeschke et al78 was used as the reference criterion for establishing a successful outcome. This decision was based on the fact that the GROC is considered to be a valid reference standard for identifying clinically important change.78 The scale ranges from ⫺7 (“a very great deal worse”) to 0 (“about the same”) to ⫹7 (“a very great deal better”). Intermittent descriptors of worsening or improving are assigned values from – 6 to ⫹6, respectively. Scores of ⫹4 and ⫹5 are reported to indicate moderate changes in patient status, and scores of ⫹6 and ⫹7 indicate large changes in patient status.78 Individuals who rated their perceived recovery on the GROC as “a very great deal better,” “a great deal better,” “quite a bit better,” or “moderately

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better” (ie, a score of ⫹4 or greater) at follow-up were categorized as having a successful outcome. We set ⫹4 as the threshold for success because this score represents clinically meaningful improvements and, due to the short duration of this study, it would be likely that the clinical outcome would be attributable to the intervention rather than the passage of time.78 We chose not to use the SPADI, as it may not adequately capture low levels of disability.79 At the beginning of the second session, the participants completed the GROC and the other outcome measures. If their score on the GROC did not exceed the ⫹4 cutoff at the second session, they received the same intervention program again and were scheduled for a follow-up within 2 to 4 days. Participants again completed the GROC along with the other outcome measures. If they scored ⫹4 or better on the GROC, they were categorized as having a successful outcome; if they scored below ⫹4, they were categorized as not having a successful outcome. At this point, their participation in the study was complete, and the therapist could administer further treatment as needed. Data Analysis We used SPSS version 16.0* to analyze the data. Individuals were dichotomized as having or not having a successful outcome based on the treatment response, as indicated on the GROC (⫺7 to ⫹3⫽nonsuccessful outcome, ⫹4 to ⫹7⫽successful outcome). The mean NPRS and SPADI change scores (and 95% confidence intervals [CIs]) were calculated for the success and nonsuccess groups and were analyzed using an independent t test to determine whether any differences existed between groups. Individual variables * SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606.

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation from self-report measures, the history, and the physical examination were tested for univariate relationship with the GROC reference criterion using independent-samples t tests for continuous variables and chi-square tests for categorical variables. Variables with a significance level of P⬍.10 were retained as potential prognostic variables.80 A liberal significance level was selected to increase the likelihood that no potential prognostic variables would be overlooked. For continuous variables with a significant univariate relationship, sensitivity and specificity values were calculated for all possible cutoff points and then plotted as a receiver operator characteristic (ROC) curve.81 The point on the curve nearest the upper left-hand corner represented the value with the best diagnostic accuracy, and this point was selected as the cutoff defining a positive test.81 Sensitivity, specificity, and positive and negative likelihood ratios (⫹LR and ⫺LR) were calculated for potential prognostic variables. Potential prognostic variables were entered into a stepwise logistic regression model to determine the most accurate set of variables for prediction of treatment success. A significance level of P⬍.10 was set to increase the likelihood that no potential prognostic variables would be overlooked.80 The Hosmer-Lemeshow goodness-of-fit statistic was used to assess if the model fit the data.82 Variables retained in the regression model were factors that might predict which individuals with shoulder pain are likely to benefit rapidly and dramatically from manual therapy interventions directed at the cervicothoracic spine. Cohen kappa (␬)83 was used to calculate the interrater reliability of categorical data for identified prognostic variables from the patient history and clinical examination. Intraclass January 2010

correlation coefficients (2,1) and the 95% CIs were calculated to determine the interrater reliability for continuous variables identified as potential prognostic variables.84 Role of the Funding Source This study was supported by a grant from the American Academy of Orthopaedic Manual Physical Therapists.

Results Between October 2006 and December 2008, 131 individuals with a primary report of shoulder pain who were seen for physical therapy were screened for eligibility criteria. Eighty individuals (61%) satisfied the criteria for the study and agreed to participate. The total number of participants screened and reasons for ineligibility are shown in Figure 1. Patient demographics and initial baseline scores for self-report measures are shown in Table 1. Clinical examination variables for the entire sample and both the success and nonsuccess groups, as well as the reliability values, are shown in eTable 1 (available at ptjournal. apta.org) for categorical variables and eTable 2 (available at ptjournal. apta.org) for continuous variables. Of the 80 individuals who enrolled in the study, a total of 49 (61%) experienced a successful outcome. Thirty-one individuals (63% of those who experienced a successful outcome) experienced a successful outcome at the time of the second visit. The remaining 18 individuals reported a successful outcome at the third visit (following 2 treatment sessions). No adverse events were reported during the study. Data for individual therapists were analyzed separately, and there was no heterogeneity among therapists’ average outcomes. Specifically, the percentage of successful patients per therapist was analyzed using chisquare tests, and the results were not

significant (P⫽.425). Additionally, changes on the SPADI and the NPRS were analyzed using an analysis of variance (ANOVA), and there was no significant difference among therapists for these outcomes (P⫽.44 and .113, respectively). Baseline scores, final scores, and change scores with 95% CIs for all outcomes scales for the success and nonsuccess groups are reported in Tables 2 and 3. Differences in change scores for the SPADI for the success group were significantly better than for the nonsuccess group (P⬍.001), with a mean difference between groups of 12.9 (95% CI⫽7.3, 18.5). The mean SPADI score for the success group decreased by more than 50% (from 38.1 to 18.4), whereas the mean SPADI score for the nonsuccess group decreased by 18% (from 37.9 to 30.4) (Fig. 2A). Additionally, analysis of NPRS change scores revealed the success group experienced significantly greater improvements compared with the nonsuccess group, with a mean difference between-group change of 1.7 (95% CI⫽1.1, 2.3) (Fig. 2B). The success group exceeded the MCID for both the SPADI79 and the NPRS85 (19.7 and 2.2, respectively). The participants’ ability to flex the shoulder without pain also improved significantly in both groups (P⬍.001). Differences in change scores for pain-free shoulder flexion were significantly better for the success group than for the nonsuccess group, both immediately after treatment (P⫽.017) and at the final visit (P⬍.001), with mean differences between groups of 7.5 degrees (95% CI⫽1.4°, 13.7°) and 13.8 degrees (95% CI⫽6.2°, 21.4°), respectively (Tab. 3, Fig. 3). The 14 potential prognostic variables (Tab. 4) that exhibited a significance level of less than .10 were

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Figure 1. Flow diagram showing participant recruitment and retention. CNS⫽central nervous system, UE⫽upper extremity, SPADI⫽Shoulder Pain and Disability Index, GROC⫽Global Rating of Change.

entered into the logistic regression. The cutoff values determined by the ROC curve analysis were 90 days since the onset of symptoms and pain-free shoulder flexion of ⬍127 degrees. We dichotomized duration of symptoms to greater or less than 90 days. Accuracy statistics for all 14 32

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variables (and 95% CIs) are shown in Table 4. The ⫹LRs ranged from 1.1 to 3.0. Of the 14 variables that were entered into the regression model, 5 were retained as the most parsimonious group of prognostic variables for identifying individuals with shoulder pain likely to benefit rap-

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idly and dramatically from manual therapy interventions targeting the cervicothoracic region (Nagelkerke R2⫽.56). The Hosmer-Lemeshow goodness-of-fit statistic indicated the model fit the data (P⫽.90).

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Table 1. Demographics, Baseline Self-Report Variables, and Baseline Characteristics of Participantsa Success Group (nⴝ49)

Variable

Nonsuccess Group (nⴝ31)

P

Age (y)

40.4 (13.5)

42.5 (12.8)

.51b

Sex: female, n (%)

29 (59%)

19 (61%)

.52c

Duration of symptoms (d), mean (SD), median

482.39 (1,635.5), 99

555.84 (1,289.5), 225

.15d

4.0 (1.7)

4.3 (1.8)

.42b

SPADI score (0–100)

38.1 (13.9)

37.9 (13.1)

.93b

FABQ-PA score (0–24)

13.1 (4.8)

12.7 (6.4)

.80b

FABQ-W score (0–42)

10.7 (8.8)

TSK score (0–55)

22.7 (4.4)

21.9 (6.0)

.53b

BMI (kg/m )

24.5 (4.2)

26.4 (5.9)

.11b

Prior history of shoulder pain, n (%)

24 (49%)

18 (58%)

.50c

Traumatic injury, n (%)

13 (27%)

11 (35%)

.45c

Symptoms distal to the shoulder

11

17

.004c

Taking medications, n (%)

30 (61%)

25 (81%)

.07c

NPRS score

2

8.9 (10.3)

.41b

a

Data are mean (SD) unless otherwise indicated. NPRS⫽numeric pain rating scale, SPADI⫽Shoulder Pain and Disability Index, FABQ-PA⫽Fear-Avoidance Beliefs Questionnaire–physical activity subscale, FABQ-W⫽Fear-Avoidance Beliefs Questionnaire–work subscale, TSK⫽Tampa Scale of Kinesiophobia, BMI⫽body mass index. b Independent-samples t test. c Chi-square test. d Mann-Whitney U test.

The pretest probability for the likelihood of success with manual therapy and general mobility exercises for this study was 61% (49 out of 80 participants). If the patient exhibited 4 or 5 out of the 5 variables, the diagnostic accuracy was maximized (⫹LR was infinity), with a posttest probability of success at 100% (Tab. 5). The accuracy of predicting success when 3 out of 5 variables were present (⫹LR⫽5.3, 95% CI⫽1.7, 16.0) was 89%. The accuracy decreased to 78% if only 2 out of

5 variables were present. Reliability data for all variables are presented in eTables 1 and 2 (available at ptjournal.apta.org).

Discussion We have identified several prognostic factors that can potentially identify, a priori, individuals with shoulder pain who are likely to experience a rapid and dramatic response to manual therapy and ROM directed to the cervicothoracic spine. This information may be use-

ful for guiding clinical decision making for individual patients. The results of our study suggest that 61% of individuals with shoulder pain are likely to experience a successful outcome with this intervention program. If 3 out of 5 variables were present (⫹LR⫽5.3, 95% CI⫽1.7, 16.0), the likelihood of success increased to 89%. All individuals who met 4 or 5 of the variables had a positive outcome (⫹LR⫽⬁, posttest probability⫽100%). According to the criteria described by Landis and

Table 2. Baseline, Final, and Change Scores for Outcome Measures Baseline Mean (SD)

Final Mean (SD)

Success group

38.1 (13.9)

18.4 (12.0)

19.7 (15.5, 20.0)

Nonsuccess group

37.9 (13.1)

30.4 (13.7)

6.9 (4.6, 9.1)

Outcome Measure

Within-Group Change Score (95% CIa)

Between-Group Change Scores (95% CI)

Shoulder Pain and Disability Index (0–100) 12.9 (7.3, 18.5) P⬍.001

Numeric pain rating scale (0–10)

a

Success group

4.0 (1.7)

1.8 (1.1)

2.2 (1.9, 2.6)

Nonsuccess group

4.3 (1.8)

3.9 (1.5)

0.50 (⫺0.08, 0.90)

1.7 (1.1, 2.3) P⬍.001

CI⫽confidence interval.

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Table 3. Baseline, Immediate Posttreatment, and Final Session Degrees of Pain-Free Shoulder Flexion Baseline Mean (SD)

Final Mean (SD)

Within-Group Change Scores (95% CIa)

Between-Group Change Scores (95% CI)

Success group

118.6 (31.0)

142.0 (29.8)

23.1 (19.1, 27.2)

Nonsuccess group

134.7 (24.4)

150.1 (20.6)

15.6 (11.1, 20.1)

7.5 (1.4, 13.7) P⫽.017

Success group

118.6 (31.0)

149.3 (25.1)

30.4 (25.1, 35.7)

Nonsuccess group

134.7 (24.4)

151.1 (19.1)

16.6 (11.9, 21.3)

Variable Pain-free shoulder flexion, pretreatment to immediate posttreatment

Pain-free shoulder flexion, pretreatment to final visit

a

13.8 (6.2, 21.4) P⬍.001

CI⫽confidence interval.

Koch,86 all prognostic variables exhibited moderate to substantial reliability. We consider these reliability coefficients acceptable to guide clinical decision making in the treatment of individuals with shoulder pain. The 5 prognostic variables that were retained in the regression model

were: pain-free shoulder flexion of ⬍127 degrees, shoulder internal rotation of ⬍53 degrees, a negative Neer test, not taking medications of any kind for shoulder pain, and duration of symptoms of ⬍90 days. Two variables from the patient history provided an indication that this subgroup is more likely to experi-

Figure 2. (A) Line graph for Shoulder Pain and Disability Index (SPADI) scores of intervention time (P⬍.001 for both groups). (B) Line graph for numeric pain rating scale (NPRS) scores of intervention time (P⬍.001 for success group).

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ence improvement if they are not taking medications and have a shorter duration of symptoms. Brox and Brevik87 reported that not taking medications was a prognostic factor for success in individuals with rotator cuff tendinosis. A longer duration of symptoms frequently has been shown to be associated with a poorer prognosis.88 –90 Two studies have shown that a duration of symptoms of ⬎3 months predict persistent shoulder symptoms and increased sick leave.88 –90 Although a duration of symptoms of ⱕ90 days was one of the strongest predictors of successful outcome, we used a high threshold for defining success on the GROC78 to attempt to distinguish between patients who improved significantly with manipulation and those who were improving over time due to natural history of the disorder. Finally, the magnitude of the difference in change scores for both the SPADI and the NPRS substantiates that an important clinical change occurred in the success group. Two of the prognostic variables included limitations in shoulder motion: pain-free shoulder flexion of ⬍127 degrees and shoulder internal rotation of ⬍53 degrees. These limitations in shoulder motion could be linked to restricted spine and rib

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Winters et al25 found that subjects with purely shoulder girdle disorders (pain or limited motion in the cervical spine, the thoracic spine, or the adjoining ribs) had better outcomes when randomized to receive manipulation (including manipulation of the cervical spine, upper thoracic spine, upper ribs, acromioclavicular joint, and glenohumeral joint) versus conventional physical therapy. As the Neer test has been shown to be sensitive and not specific,56,58 perhaps it serves as a good test to rule out structures that are mechanically painful around the glenohumeral joint and may cue the clinician to focus on the cervicothoracic spine and ribs.

Figure 3. (A) Line graph for changes in pain-free shoulder flexion immediately posttreatment (P⬍.001 for both groups). (B) Line graph for changes in pain-free shoulder flexion from initial visit to final visit (P⬍.001 for both groups).

cage ROM. Decreased thoracic spine ROM has been associated with a functional restriction of arm movement.91,92 Crosbie et al23 found that there is significant movement in the thoracic spine with unilateral and bilateral arm elevation. Sobel et al26 reported that impaired cervicothoracic mobility may be an intrinsic cause of shoulder pain. Painful shoulder elevation may be caused by restricted cervicothoracic spine motion.16 –18,46 Interestingly, both groups in our study improved significantly (P⬍.001) in the degree of pain-free shoulder flexion following the manipulative interventions. Additionally, it is possible that the changes we observed were due to a neurophysiological effect of manipulation that may be unrelated to any biomechanical effects or changes. There is a significant body of literaJanuary 2010

ture demonstrating that spinal manipulation affects the flow of sensory information to the central nervous system, evokes paraspinal muscle reflexes, alters motoneuron excitability, and increases pain tolerance or its threshold.93–96 We were surprised that a negative Neer test was predictive of success. The trials by Boyles et al24 and Bang and Deyle27 required that subjects have either a positive Neer test or a positive Hawkin-Kennedy test. However, it has been reported that many individuals with shoulder pain have no significant impairments in the glenohumeral structures.20,25 Sobel et al20 and Winters et al25 reported that up to a third of subjects with shoulder pain had no identifiable shoulder “synovial impairments” beyond impaired cervicothoracic mobility.

This study successfully developed a set of prognostic factors that may help identify individuals with shoulder pain who are likely to experience meaningful changes in pain, disability, and ROM following cervicothoracic manipulation and general mobility exercises. We believe that these results are generalizable to individuals with a primary report of shoulder pain seeking physical therapy care, as data were collected by 9 physical therapists at 7 outpatient clinics across the country. There were no differences in outcomes among clinicians with varying levels of experience; therefore, it is unlikely that any potential clustering effect based on an individual therapist would have biased the results. It should be noted that this is only the first step in the process of identifying prognostic variables.97 Future studies will be necessary to validate the predictive value of the prognostic factors in a randomized controlled trial with a comparison group and a longer-term follow-up. Ultimately, if these variables do turn out to be useful guides to clinical decision making, an impact analysis should be performed to determine the effects on economic factors, clinical practice patterns, and patient outcomes.

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Table 4. Accuracy Statistics with 95% Confidence Intervals (CIs) for Individual Predictor Variablesa Sensitivity (95% CI)

Specificity (95% CI)

Positive Likelihood Ratio (95% CI)

Posttest Probability (%)

Symptoms ⬍90 d

.47 (.33, .62)

.84 (.66, .94)

2.9 (1.2, 6.6)

81.9

Pain-free shoulder flexion ⬍127°

.59 (.44, .73)

.74 (.55, .87)

2.3 (1.2, 4.4)

78.3

Variable

a

Shoulder internal rotation ⬍53° at 90° of abduction

.78 (.63, .88)

.53 (.35, .71)

1.7 (1.1, 2.5)

72.7

Scapula Index greater than 66.5

.57 (.42, .71)

.67 (.47, .82)

1.7 (0.98, 3.0)

72.7

Pain with cervical range of motion

.55 (.40, .69)

.67 (.47, .82)

1.7 (0.99, 2.9)

72.7

Hypomobility of either first rib

.94 (.82, .98)

.23 (.10, .43)

1.2 (0.99, 1.5)

65.2

Weak middle trapezius muscle

.65 (.49, .77)

.6 (.41, .77)

1.6 (0.99, 2.6)

71.5

No deltoid muscle weakness

.77 (.62, .87)

.52 (.31, .71)

1.1 (1.1, 2.4)

63.2

No symptoms distal to shoulder

.77 (.62, .87)

.57 (.38, .74)

1.8 (1.1, 2.8)

71.8

Scapular symptoms

.71 (.57, .83)

.65 (.45, .80)

2.0 (1.2, 3.3)

75.8

Painful arc with flexion

.29 (.17, .43)

.90 (.73, .97)

3.0 (0.92, 9.4)

82.4

Negative active compression test

.73 (.59, .85)

.47 (.29, .65)

1.3 (0.95, 2.0)

67

Negative Neer test

.50 (.35, .65)

.73 (.54, .87)

1.9 (0.97, 3.6)

74.8

Not taking medications

.38 (.24, .53)

.83 (.65, .94)

2.3 (0.93, 5.4)

78.3

Pretest probability of success⫽61%.

There are limitations to the current study that should be recognized. First, a prospective single-arm design lacking a comparison group does not allow for inferences to be made regarding cause and effect. Weeks98 stated that single-arm studies are the most vulnerable to a regression effect, as the absence of a control

group makes it impossible to determine the amount of change due to regression. The regression effect is defined as a statistical phenomenon in which a finding that may seem significant on first analysis will tend to be closer to the mean of a group on a subsequent measurement.98 It is possible that the statistical proce-

dures used may have resulted in overfitting of the model, which may have resulted in low precision of the prediction accuracy.99 Therefore, the values for sensitivity, specificity, and LRs presented here may be higher than they actually were. Furthermore, it is possible that the prognostic variables were not reliably se-

Table 5. Clinical Prediction Rule Criteria Identified in the Logistic Regression Analysis and Their Accuracy Statistics Clinical Prediction Rule Criteria Identified in Logistic Regression Analysis Pain-free shoulder flexion ⬍127° Shoulder internal rotation ⬍53° at 90° of abduction Negative Neer test Not taking medications for their shoulder pain Symptoms less than 90 d Probability of Success (%)a

.04 (.01, .15)

1.0 (.86, 1.0)

⬁

100

2

0

.27 (.15, .41)

1.0 (.86, 1.0)

⬁

100

13

0

Patients Who Satisfied:

Sensitivity

Met all 5 Met at least 4 Met at least 3

.51 (.37, .65)

.90 (.73, .97)

5.3 (1.7, 16.0)

89

25

3

Met at least 2

.90 (.77, .96)

.61 (.42, .78)

2.3 (1.5, 3.6)

78

44

12

.19 (.08, .38)

1.0 (1.2, 1.5)

61

49

25

Met at least 1 a

Specificity

Positive Likelihood Ratio

No. of Predictor Variables Present

1.0 (.90, 1.0)

Success

Nonsuccess

The probability of success is calculated using the positive likelihood ratios and assumes a pretest probability of 61%.

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation lected and that they may represent spurious findings rather than true prognostic variables. It also is possible that the initial screening process using bivariate analysis may have caused the rejection of some variables that actually have prediction accuracy.100 However, as is the case with all statistical modeling, the results presented here will require validation to protect against potential problems and limitations. Such validation could include performing the study on an independent sample of patients.99 It is possible that one or more of the prognostic variables simply identify individuals who have a favorable natural history rather than a response to the manual therapy and general mobility exercises. Although this may be the case, our sample included participants with relatively longstanding symptoms (65% had symptoms for greater than 90 days). We chose not to limit the duration of symptoms, as research indicates that 50% of individuals with a new onset of shoulder pain will continue to have symptoms at 6 months, and 40% still have symptoms at 1 year.11,89 In this study, the median duration of symptoms was 99 days for the success group and 225 days in the nonsuccess group. The individuals in our study with acute symptoms seemed to respond more favorably than those with chronic symptoms. The proportion of individuals with a duration of symptoms of ⬎90 days was the same for both the success group (n⫽26, 32.5%) and the nonsuccess group (n⫽26, 32.5%). The proportion of individuals with a duration of symptoms of ⬍90 days was significantly different (P⫽.005) between the success group (n⫽23, 29%) and the nonsuccess group (n⫽5, 6%). It also is possible that we did not capture every possible variable that could be a potential predictor during January 2010

the examination. We did not standardize the number of treatments, which could have affected the results. It is possible that the small sample size and the number of variables entered into the logistic regression may have resulted in overfitting of the model, which may have led to spurious findings.99 However, in order to not introduce bias into the analysis, we included all potential predictor variables, and any variable that identified as a predictor should be re-examined in future studies.99 As we collected only data for shortterm outcomes on these individuals, we do not know whether the individuals who were classified as having a successful outcome were still doing well at a longer-term follow-up. Finally, although there is a percentage of individuals with shoulder pain for whom a specific diagnosis can be made, we chose to not separate out any specific diagnoses, which potentially confounded our results. Dr Mintken, Dr Cleland, Dr Keirns, and Dr Whitman provided concept/idea/research design, writing, and fund procurement. Dr Mintken, Dr Carpenter, Dr Keirns, and Dr Bieniek provided data collection, participants, facilities/equipment, and clerical support. Dr Cleland provided data analysis. Dr Mintken provided project management. All authors provided consultation (including review of manuscript before submission). The authors thank Scott Burns, Amy Garrigues, Paul Glynn, John Groves, Tim Mondale, and Louie Puentedura for their assistance with data collection. They also thank David Weil for his production of the photographs for the figures. The study was approved by the institutional review boards at the University of Colorado at Boulder, the University of Colorado Denver, Regis University, Newton Wellesley Hospital, and Concord Hospital. This study was supported by a grant from the American Academy of Orthopaedic Manual Physical Therapists. This study is registered at www.clinicaltrials. gov: Identifier: NCT00835302.

This article was received March 20, 2009, and was accepted August 28, 2009. DOI: 10.2522/ptj.20090095

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation 15 Wainner RS, Whitman JM, Cleland JA, Flynn TW. Regional interdependence: a musculoskeletal examination model whose time has come. J Orthop Sports Phys Ther. 2007;37:658 – 660. 16 Norlander S, Aste-Norlander U, Nordgren B, Sahlstedt B. Mobility in the cervicothoracic motion segment: an indicative factor of musculo-skeletal neck-shoulder pain. Scand J Rehabil Med. 1996;28: 183–192. 17 Norlander S, Gustavsson BA, Lindell J, Nordgren B. Reduced mobility in the cervico-thoracic motion segment—a risk factor for musculoskeletal neck-shoulder pain: a two-year prospective follow-up study. Scand J Rehabil Med. 1997;29: 167–174. 18 Norlander S, Nordgren B. Clinical symptoms related to musculoskeletal neckshoulder pain and mobility in the cervico-thoracic spine. Scand J Rehabil Med. 1998;30:243–251. 19 Sobel JS, Kremer I, Winters JC, et al. The influence of the mobility in the cervicothoracic spine and the upper ribs (shoulder girdle) on the mobility of the scapulohumeral joint. J Manipulative Physiol Ther. 1996;19:469 – 474. 20 Sobel JS, Winters JC, Groenier K, et al. Physical examination of the cervical spine and shoulder girdle in patients with shoulder complaints. J Manipulative Physiol Ther. 1997;20:257–262. 21 Picavet HSJ, Schouten JSAG. Musculoskeletal pain in the Netherlands: prevalences, consequences and risk groups, the DMC(3) study. Pain. 2003;102:167– 178. 22 Bergman GJD, Winters JC, Groenier KH, et al. Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial. Ann Intern Med. 2004;141:432– 439. 23 Crosbie J, Kilbreath SL, Hollmann L, York S. Scapulohumeral rhythm and associated spinal motion. Clin Biomech. 2008; 23:184 –192. 24 Boyles RE, Ritland BM, Miracle BM, et al. The short-term effects of thoracic spine thrust manipulation on patients with shoulder impingement syndrome. Man Ther. 2009;14:375–380. 25 Winters JC, Sobel JS, Groenier KH, et al. Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice: randomised, single blind study. BMJ. 1997;314(7090):1320 –1325. 26 Bergman G, Winters J, Groenier K, et al. Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial. Ann Intern Med. 2004;141: 432– 439. 27 Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther. 2000;30:126 –137.

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28 Cleland JA, Childs JD, Fritz JM, et al. Development of a clinical prediction rule for guiding treatment of a subgroup of patients with neck pain: use of thoracic spine manipulation, exercise, and patient education. Phys Ther. 2007;87:9 –23. 29 Flynn T, Fritz J, Whitman J, et al. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine. 2002;27: 2835–2843. 30 Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005;86:1753–1762. 31 Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991;4:143–149. 32 Heald SL, Riddle DL, Lamb RL. The Shoulder Pain and Disability Index: the construct validity and responsiveness of a region-specific disability measure. Phys Ther. 1997;77:1079 –1089. 33 McCarthy CJ, Gittins M, Roberts C, Oldham JA. The reliability of the clinical tests and questions recommended in international guidelines for low back pain. Spine. 2007;32:921–926. 34 Beneciuk JM, Bishop MD, George SZ. Clinical prediction rules for physical therapy interventions: a systematic review. Phys Ther. 2009;89:114 –124. 35 Werneke MW, Hart DL, Cook D. A descriptive study of the centralization phenomenon: a prospective analysis. Spine. 1999;24:676 – 683. 36 Jensen MP, Turner JA, Romano JM. What is the maximum number of levels needed in pain intensity measurement? Pain. 1994;58:387–392. 37 Waddell G, Newton M, Henderson I, et al. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fearavoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–168. 38 Uden A, Astrom M, Bergenudd H. Pain drawings in chronic back pain. Spine. 1988;13:389 –392. 39 Werneke MW, Harris DE, Lichter RL. Clinical effectiveness of behavioral signs for screening chronic low-back pain patients in a work-oriented physical rehabilitation program. Spine. 1993;18: 2412–2418. 40 Downie WW, Leatham PA, Rhind VM, et al. Studies with pain rating scales. Ann Rheum Dis. 1978;37:378 –381. 41 Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999;79:231–252. 42 Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005;117: 137–144. 43 Beaton D, Richards RR. Assessing the reliability and responsiveness of 5 shoulder questionnaires. J Shoulder Elbow Surg. 1998;7:565–572.

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44 Viikari-Juntura E. Interexaminer reliability of observations in physical examinations of the neck. Phys Ther. 1987;67: 1526 –1532. 45 Kendall FP, McCreary EK, Provance PG. Muscles: Testing and Function. 4th ed. Baltimore, MD: Williams & Wilkins; 1993. 46 Griegel-Morris P, Larson K, Mueller-Klaus K, Oatis CA. Incidence of common postural abnormalities in the cervical, shoulder, and thoracic regions and their association with pain in two age groups of healthy subjects. Phys Ther. 1992;72: 425– 431. 47 Magee DJ. Orthopedic Physical Assessment. 4th ed. Philadelphia, PA: Saunders; 2002. 48 Yang J-l, Lin J-J. Reliability of functionrelated tests in patients with shoulder pathologies. J Orthop Sports Phys Ther. 2006;36:572–576. 49 Borstad JD. Resting position variables at the shoulder: evidence to support a posture-impairment association. Phys Ther. 2006;86:549 –557. 50 Kibler WB. The role of the scapula in athletic shoulder function. Am J Sports Med. 1998;26:325–337. 51 Kibler WB, Uhl TL, Maddux JW, et al. Qualitative clinical evaluation of scapular dysfunction: a reliability study. J Shoulder Elbow Surg. 2002;11:550 –556. 52 Tzannes A, Paxinos A, Callanan M, Murrell GAC. An assessment of the interexaminer reliability of tests for shoulder instability. J Shoulder Elbow Surg. 2004; 13:18 –23. 53 Walton J, Mahajan S, Paxinos A, et al. Diagnostic values of tests for acromioclavicular joint pain. J Bone Joint Surg Am. 2004;86:807– 812. 54 O’Brien SJ, Pagnani MJ, Fealy S, et al. The active compression test: a new and effective test for diagnosing labral tears and acromioclavicular joint abnormality. Am J Sports Med. 1998;26:610 – 613. 55 Kibler WB. Specificity and sensitivity of the anterior slide test in throwing athletes with superior glenoid labral tears. Arthroscopy. 1995;11:296 –300. 56 Calis M, Akgun K, Birtane M, et al. Diagnostic values of clinical diagnostic tests in subacromial impingement syndrome. Ann Rheum Dis. 2000;59:44 – 47. 57 Leroux JL, Thomas E, Bonnel F, Blotman F. Diagnostic value of clinical tests for shoulder impingement syndrome. Rev Rhum Engl Ed. 1995;62:423– 428. 58 MacDonald PB, Clark P, Sutherland K. An analysis of the diagnostic accuracy of the Hawkins and Neer subacromial impingement signs. J Shoulder Elbow Surg. 2000;9:299 –301. 59 Itoi E, Kido T, Sano A, et al. Which is more useful, the “full can test” or the “empty can test,” in detecting the torn supraspinatus tendon? Am J Sports Med. 1999;27:65– 68.

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73 Harris KD, Heer DM, Roy TC, et al. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005;85: 1349 –1355. 74 Maitland G, Hengeveld E, Banks K, English K. Maitland’s Vertebral Manipulation. 6th ed. Oxford, United Kingdom: Butterworth-Heinemann; 2001. 75 Jaeschke R, Guyatt GH, Sackett DL; the Evidence-Based Medicine Working Group. Users’ guides to the medical literature, III: how to use an article about a diagnostic test, B. What are the results and will they help me in caring for my patients? JAMA. 1994;271:703–707. 76 Mintken PE, DeRosa C, Little T, Smith B. A model for standardizing manipulation terminology in physical therapy practice. J Orthop Sports Phys Ther. 2008;38(3): A1–A6. 77 Erhard RE. The Spinal Exercise Handbook: A Home Exercise Manual for a Managed Care Environment. Pittsburgh, PA: Laurel Concepts; 1998. 78 Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407– 415. 79 Williams JW Jr, Holleman DR Jr, Simel DL. Measuring shoulder function with the Shoulder Pain and Disability Index. J Rheumatol. 1995;22:727–732. 80 Freedman D. A note on screening regression equations. American Statistician. 1983;37:152–155. 81 Deyo RA, Centor RM. Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. J Chronic Dis. 1986;39: 897–906. 82 Field A. Discovering Statistics Using SPSS for Windows. London, United Kingdom: Sage Publications; 2002. 83 Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960; 20:37– 46. 84 Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86:420 – 426. 85 Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine. 2005; 30:1331–1334. 86 Landis JR, Koch CG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159 –174. 87 Brox JI, Brevik JI. Prognostic factors in patients with rotator tendinosis (stage II impingement syndrome) of the shoulder. Scand J Primary Health Care. 1996;14: 100 –105.

88 Kuijpers T, van der Windt DAWM, Boeke AJP, et al. Clinical prediction rules for the prognosis of shoulder pain in general practice. Pain. 2006;120:276 –285. 89 Kuijpers T, van der Windt DAWM, van der Heijden GJMG, Bouter LM. Systematic review of prognostic cohort studies on shoulder disorders. Pain. 2004;109: 420 – 431. 90 Borg K, Hensing G, Alexanderson K. Risk factors for disability pension over 11 years in a cohort of young persons initially sick-listed with low back, neck, or shoulder diagnoses. Scand J Public Health. 2004;32:272–278. 91 Crawford HJ, Jull GA. The influence of thoracic posture and movement on range of arm elevation. Physiother Theory Pract. 1993;9:143–148. 92 Stewart S, Jull GA, Ng JK-F, Willems JM. An initial analysis of thoracic spine movement during unilateral arm elevation. J Man Manip Ther. 1995;3:15–20. 93 George SZ, Bishop MD, Bialosky JE, et al. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006;7:68. 94 Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002;2: 357–371. 95 Wright A. Hypoalgesia post-manipulative therapy: a review of a potential neurophysiological mechanism. Man Ther. 1995;1:11–16. 96 Vicenzino B, Collins D, Benson H, Wright A. An investigation of the interrelationship between manipulative therapyinduced hypoalgesia and sympathoexcitation. J Manipulative Physiol Ther. 1998;21:448 – 453. 97 McGinn TG, Guyatt GH, Wyer PC, et al; Evidence-Based Medicine Working Group. Users’ guides to the medical literature, XXII: how to use articles about clinical decision rules. JAMA. 2000;284:79 – 84. 98 Weeks DL. The regression effect as a neglected source of bias in nonrandomized intervention trials and systematic reviews of observational studies. Evaluation and the Health Professions. 2007; 30:254 –265. 99 Concato J, Feinstein A, Holford T. The risk of determining risk with multivariable models. Ann Intern Med. 1993;118: 201–210. 100 Sun GW, Shook TL, Kay GL. Inappropriate use of bivariable analysis to screen risk factors for use in multivariable analysis. J Clin Epidemiol. 1996;49:907–916.

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Appendix 1. Manual Therapy Interventions

Seated thoracic spine thrust manipulation. The therapist uses his sternum as a fulcrum on the individual’s middle thoracic spine and applies a high-velocity distraction thrust in an upward direction.

The treating therapist cradles the individual’s head and neck and performs a lateral translation (Maitland grades III and IV) to the right and left in neutral and flexion, 3 bouts of 30 seconds from C5 to C7.

Supine cervicothoracic thrust manipulation technique. The therapist uses his body to push down through the individual’s elbows to perform a high-velocity, low-amplitude thrust directed toward moving C7 on T1.

(Continued)

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Appendix 1. Continued

Supine upper thoracic spine thrust manipulation technique. The therapist uses his body to push down through the individual’s arms to perform a high-velocity, lowamplitude thrust directed in the direction of the arrow toward T1 through T4.

Supine middle thoracic spine thrust manipulation technique. The therapist uses his body to push down through the individual’s arms to perform a high-velocity, lowamplitude thrust directed in the direction of the arrow toward T5 through T8.

Prone middle to lower thoracic spine thrust manipulation technique. The therapist achieves a “skin lock” with the pisiforms of each hand over the transverse processes of the target vertebra pushing caudal with one hand and cephalad with the other. The therapist then uses his body to push down through his arms to perform a high-velocity, low-amplitude posterior to anterior thrust.

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Prognosis in Individuals With Shoulder Pain Receiving Cervicothoracic Manipulation Appendix 2. General Spinal Mobility Exercises

Active-range-of-motion (AROM) exercises performed by participants in the study: 3-finger cervical AROM and supine thoracic extension over a towel.

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Research Report Early Postoperative Measures Predict 1- and 2-Year Outcomes After Unilateral Total Knee Arthroplasty: Importance of Contralateral Limb Strength Joseph A. Zeni Jr, Lynn Snyder-Mackler

Background. Total knee arthroplasty (TKA) has been shown to be an effective surgical intervention for people with end-stage knee osteoarthritis. However, recovery of function is variable, and not all people have successful outcomes. Objective. The aim of this study was to discern which early postoperative functional measures could predict functional ability at 1 year and 2 years after surgery.

Design and Methods. One hundred fifty-five people who underwent unilateral TKA participated in the prospective longitudinal study. Functional evaluations were performed at the initial outpatient physical therapy appointment and at 1 and 2 years after surgery. Evaluations consisted of measurements of height, weight, quadriceps muscle strength (force-generating capacity), and knee range of motion; the Timed “Up & Go” Test (TUG); the stair-climbing task (SCT); and the Knee Outcome Survey (KOS) questionnaire. The ability to predict 1- and 2-year outcomes on the basis of early postoperative measures was analyzed with a hierarchical regression. Differences in functional scores were evaluated with a repeated-measures analysis of variance. Results. The TUG, SCT, and KOS scores at 1 and 2 years showed significant improvements over the scores at the initial evaluation (P⬍.001). A weaker quadriceps muscle in the limb that did not undergo surgery (“nonoperated limb”) was related to poorer 1- and 2-year outcomes even after the influence of the other early postoperative measures was accounted for in the regression. Older participants with higher body masses also had poorer outcomes at 1 and 2 years. Postoperative measures were better predictors of TUG and SCT times than of KOS scores.

J.A. Zeni Jr, PT, PhD, is Research Assistant Professor, Department of Physical Therapy, University of Delaware, 301 McKinly Laboratory, Newark, DE 19716 (USA). Address all correspondence to Dr Zeni at: [email protected]. L. Snyder-Mackler, PT, ScD, FAPTA, is Alumni Distinguished Professor, Department of Physical Therapy, and Academic Director, Graduate Program in Biomechanics and Movement Science, University of Delaware. [Zeni JA Jr, Snyder-Mackler L. Early postoperative measures predict 1and 2-year outcomes after unilateral total knee arthroplasty: importance of contralateral limb strength. Phys Ther. 2010;90: 43–54.] © 2010 American Physical Therapy Association

Conclusions. Rehabilitation regimens after TKA should include exercises to improve the strength of the nonoperated limb as well as to treat the deficits imposed by the surgery. Emphasis on treating age-related impairments and reducing body mass also might improve long-term outcomes.

Post a Rapid Response or find The Bottom Line: www.ptjournal.org January 2010

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T

otal knee arthroplasty (TKA) has been proven to be an effective and cost-efficient intervention for end-stage knee osteoarthritis (OA). Most people who undergo TKA show marked improvements in function and reductions in pain compared with their preoperative condition.1,2 However, recovery of functional ability is variable, and not all patients experience significant improvements.3,4 The ability to predict which patients will have successful recoveries relies on the ability to identify factors that result in different functional outcomes. Preoperative measures that predict postsurgical functional status were examined in many previous investigations. Lower levels of preoperative quadriceps muscle strength (forcegenerating capacity) and selfperceived functional ability and a larger number of comorbidities have been shown to predict decreased functional ability 6 to 24 months after TKA.4 – 6 In the short term, greater preoperative knee pain and less preoperative range of motion (ROM) are related to reduced walking ability 2 months after surgery.7 Other factors, such as a high body mass index (BMI), female sex, and older age, have been implicated as factors that predict poor short-term outcomes, higher per-patient costs, or higher postoperative complication rates.8,9 Although preoperative predictors may aid in the identification of people at risk for postoperative difficulties, it also is important to recognize

Available With This Article at ptjournal.apta.org • Audio Abstracts Podcast This article was published ahead of print on December 3, 2009, at ptjournal.apta.org.

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early postoperative factors that may predict poor long-term outcomes. Van den Akker-Scheek et al10 found that early postoperative evaluations of self-efficacy were better predictors of long-term outcomes than preoperative evaluations. This finding is important because most people receive outpatient physical therapy services after TKA, but preoperative therapeutic interventions are not as common. Physical therapists, therefore, can tailor rehabilitation regimens to maximize early postoperative self-efficacy, whereas increasing preoperative self-efficacy is not always feasible. No studies have evaluated the ability to predict long-term functional outcomes on the basis of early postoperative measures. The purpose of this study was to discern whether age, BMI, pain, knee ROM, and knee strength measured at an initial physical therapy evaluation could predict functional ability at 1 year and 2 years after surgery. We hypothesized that certain factors would best predict long-term outcomes. Identification of these factors will aid in the creation of targeted therapeutic interventions to maximize postoperative functional ability.

Method One hundred and fifty-five people who underwent primary unilateral TKA for end-stage knee OA participated in the study (Tab. 1). Before surgery, participants were excluded if they reported symptomatic OA in the contralateral limb, as measured by maximal pain of greater than 4 on a scale of 1 to 10 in that limb during daily activities. All participants signed an informed consent form approved by the Human Subjects Review Board of the University of Delaware. Participants were treated 2 or 3 times per week for 6 weeks in the same outpatient physical therapy clinic. Outpatient physical therapy began shortly after they concluded

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home-based therapy (under direct physical therapist supervision) and had their staples removed. The physical therapy regimen consisted of progressive lower-extremity strengthening exercises, modalities to control pain and inflammation, electrical stimulation to improve quadriceps muscle function, and manual therapy to improve ROM (Appendix). Quantitative clinical measurements were obtained at the initial evaluation and at 1 and 2 years after surgery. These measurements included age, height, weight, bilateral quadriceps muscle strength, knee flexion and extension ROM, the Timed “Up & Go” Test (TUG), and a stairclimbing task (SCT). Two subsets of the Knee Outcome Survey (KOS), the activities of daily living subset (KOS-ADLS) and the pain subset (KOS-Pain), also were used. Quadriceps Muscle Strength Quadriceps muscle strength was defined in this study as the volitional isometric force created by the quadriceps muscle. It was measured with the participants seated with their knees flexed to 75 degrees and their hips flexed to 85 degrees on a KinCom dynamometer.* Knee flexion of 75 degrees was chosen to ensure consistency between time points and participants. After surgery, it was likely that a percentage of the participants would not be able to achieve knee flexion of greater than 75 degrees. Seventy-five degrees of knee flexion during isometric knee extension also results in the greatest force output of the quadriceps muscle after TKA.11 Participants were given verbal encouragement to kick “as hard as possible” for 3 seconds. Three trials were completed, and the average of these trials was recorded. The raw force measured by the dy* Isokinetic International, 6426 Morning Glory Dr, Harrison, TN 37341.

January 2010

Early Measures After Unilateral Total Knee Arthroplasty namometer, in newtons, was normalized to each participant’s BMI (N/ BMI), and this value was used as quadriceps muscle strength.

Table 1. Participant Demographics at Initial Evaluation, 1 Year, and 2 Yearsa

Characteristicb

Knee ROM Active knee flexion ROM was measured with participants in the supine position. The axis of the goniometer was aligned over the lateral epicondyle of the femur. The distal arm was aligned with the lateral malleolus of the fibula, and the proximal arm was aligned with the long axis of the shaft of the femur and directed toward the greater trochanter. Participants were instructed to maximally bend their knees by flexing their hips and sliding their heels toward their buttocks. No overpressure was applied by the therapist during knee flexion. Three trials were performed, and the average knee flexion angle was recorded. All measurements were obtained with respect to full extension of the knee being 0 degrees and increasing knee flexion being recorded as positive values. Goniometric measurements in people with knee OA have been shown to be highly reliable.12 TUG The TUG is a functional test that has been used extensively to examine functional outcomes in people with knee OA and after TKA.5,13,14 The test begins with a participant seated in a chair with both feet touching the floor. When instructed to “go,” the participant rises from the chair, walks 3 m, turns around, returns to the chair, and sits down. Participants were instructed to complete the task as quickly as possible. They performed 2 trials, and the average time to complete the task was recorded. They were permitted to use the arms of the chair during standing and returning to a seated position. This test has excellent interrater and intrarater reliability in older adults and is responsive to changes after TKA.15,16 January 2010

Age, y

64.9 (8.7)

Sex, % of men/women

57/43

Height, m

2 Years (nⴝ125)

1.72 (0.10) 89.1 (17.0)

91.2 (17.5)

94.1 (18.6)

BMI, kg/m2

30.2 (4.9)

31.0 (5.2)

31.8 (5.7)

6.3 (4.1)

0.4 (2.8)

0.3 (2.9)

97.1 (15.0)

120.1 (10.4)

120.2 (11.3)

9.9 (4.1)

20.7 (8.5)

20.6 (8.8)

Nonoperated quadriceps muscle strength, N/BMI

24.0 (8.7)

22.7 (9.4)

21.0 (9.3)

Days since surgery

27.7 (3.7)

Flexion AROM, ° Operated quadriceps muscle strength, N/BMI

b

1 Year (nⴝ155)

Weight, kg

Extension AROM, °

a

Initial Evaluation (nⴝ155)

Values are reported as mean (SD) unless otherwise indicated. BMI⫽body mass index, AROM⫽active range of motion.

SCT The SCT is a measure of a participant’s ability to ascend and descend a flight of 12 steps as quickly as possible in a safe manner. Participants began at the bottom of the stairs and, at the investigator’s instruction, ascended the steps, turned around, and descended the steps as quickly as possible with the use of the handrail only if needed for balance. Participants performed 1 practice trial and then 2 timed trials, the average of which was recorded. This test has been used to successfully measure recovery after TKA.5,15,17 KOS For the purpose of this study, we used 2 subsets of the KOS, the KOSADLS and the KOS-Pain. The KOSADLS consists of 14 questions pertaining to a participant’s ability to perform activities of daily living. The KOS-ADLS is represented as a percentage score, with higher scores indicating higher levels of selfperceived functional ability. With the KOS-Pain, participants rate their pain on a 6-point scale, in which 0 represents no pain and 5 represents pain that prevents daily activities.

The KOS has been shown to have high reliability and validity in people with knee pathology.18,19 Data Analysis A hierarchical regression model was created to predict the TUG, SCT, and KOS-ADLS scores at 1 and 2 years after TKA. Baseline test scores and then participant age, BMI, KOS-Pain score, flexion ROM, quadriceps muscle strength of the limb that underwent TKA (“operated limb”), and quadriceps muscle strength of the limb that did not undergo TKA (“nonoperated limb”), all obtained at the initial physical therapy evaluation, were entered into the hierarchical regression model as independent variables, in that order. The order of the variables was chosen on the basis of their clinical relevance, and the baseline test scores were entered first to account for changes in each variable over time. Preoperative quadriceps muscle strength and knee ROM are predictors of postoperative outcomes and often are directly addressed during postoperative physical therapy.5,7 For this reason, the order of the regression was designed to determine whether

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Physical Therapy f

45


Figure 1. Significant improvements in results of the Timed “Up & Go” Test (TUG) and stairclimbing task (SCT) and in scores on the activities of daily living subset of the Knee Outcome Survey (KOS-ADLS) at 1-year follow-up and 2-year follow-up (asterisk indicates P⬍.001). Error bars represent 95% confidence intervals.

knee strength and ROM would significantly improve the predictive ability of the model, even when the influence of age, BMI, knee pain, and baseline test scores was accounted for. A change in the F score from each step of the model to the next (the addition of each variable) was analyzed for significance (Pⱕ.05). An analysis of variance with 1 repeated measure (time) was used to determine differences in the TUG, SCT, and KOS-ADLS scores at the initial evaluation and those at 1 and 2 years after TKA.

Results Participants reported to outpatient physical therapy an average (median) of 28 days after TKA. The median number of physical therapy treatments was 17, with 90% of the participants receiving 16 to 18 treatments. No participants reported any major neurological or cardiovascular events after surgery. The Mauchley test of sphericity was significant, suggesting unequal variances between the time points. When the Green46

f

Physical Therapy

Volume 90

house–Geisser correction was used, a significant effect of time on all of the outcome measures was revealed. The TUG, SCT, and KOS scores at 1 and 2 years showed significant improvements over the scores at the initial evaluation (P⬍.001) (Fig. 1). The TUG and SCT showed 34% and 53% reductions in the times needed to complete the tasks at the initial evaluation and at 1 year, respectively. The KOS-ADLS score increased by 52% between the initial evaluation and 1 year. Post hoc testing revealed no significant differences between 1 and 2 years (P⬎.43). For descriptive purposes, the TUG, SCT, and KOS-ADLS scores at 3 months after TKA (near the time of discharge from physical therapy) were 8.23 seconds (SD⫽1.87 seconds), 13.63 seconds (SD⫽4.76 seconds), and 78.6% (SD⫽12%), respectively. Early postoperative values were predictive of the TUG, SCT, and KOS scores at 1 year after TKA (Tabs. 2, 3, and 4). After the other variables in the regression were accounted for,

Number 1

the quadriceps muscle strength of the nonoperated limb significantly improved the predictive ability of the model with respect to the TUG, SCT, and KOS-ADLS scores. Increased force production in the nonoperated limb was related to improved scores on the TUG, SCT, and KOS (Fig. 2). Age also improved the predictive ability of the model for the TUG and SCT times, and BMI improved the predictive ability for the SCT time. A younger age and a lower BMI predicted better functional outcomes in terms of faster times to complete the TUG and SCT. The KOS-Pain and strength of the involved limb did not predict scores for outcomes. The BMI was the most significant predictor of the KOSADLS score (P⫽.023), with a higher postoperative BMI predicting a lower KOS-ADLS score at 1 year after TKA. A stronger quadriceps muscle in the nonoperated limb also significantly contributed to the prediction of an improved KOS-ADLS score, whereas age, the KOS-Pain, knee flexion ROM, and quadriceps muscle strength of the operated limb did not. One hundred twenty-five participants returned for the 2-year followup. The remaining 30 participants either failed to return for the 2-year follow-up or had undergone TKA less than 2 years earlier. Similar to the 1-year results, the quadriceps muscle strength of the nonoperated limb significantly improved the ability of the model to predict the TUG and SCT times at 2 years after TKA, even when the other variables were accounted for (Pⱕ.011) (Tabs. 2 and 3). Age also significantly added to the predictive ability of the model for the TUG and SCT times, whereas the BMI, KOS-Pain, knee flexion ROM, and quadriceps muscle strength of the operated limb did not. The trends were the same as those at 1 year, with a stronger quadriceps muscle and a younger age predicting January 2010

Early Measures After Unilateral Total Knee Arthroplasty Table 2. Timed “Up & Go” Test Results Modela

Year 1

2

R

R2

R2 Change

F Change

Significance of F Changeb

TUG

.587

.345

.345

80.581

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Journal of Neurologic Physical Therapy (March 2010, Volume 34, Issue 1)

Manual Therapy Journal - Volume 11, Issue 1, Pages 1-90 (February 2006)

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sports medicine Volume 40 Issue 1 January 2010

Reflections Journal Issue 1

Israel Journal of Mathematics, Volume 1, Issue 1 (1963)

Journal of Semantics, Volume 1, Issue 1, 1982

Microsoft Architects Journal: Journal 1 (January, 2004)

Applied Linguistics, Volume 31, issue 1, 2010

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Physical Therapy- Journal of the APTA, Volume 90, Issue 1 (January 2010)

Physical Therapy- Journal of the APTA, Volume 90, Issue 7 (July 2010)

Physical Therapy- Journal of the APTA, Volume 90, Issue 2 (February 2010)

Physical Therapy- Journal of the APTA, Volume 90, Issue 3 (March 2010)

Physical Therapy- Journal of the APTA, Volume 90, Issue 6 (June 2010)

Physical Therapy- Journal of the APTA, Volume 90, Issue 4 (April 2010)

Physical Therapy- Journal of the APTA, Volume 90, Issue 5 (May 2010)

Physical Therapy- Journal of the APTA- January 2009, Volume 89, Issue 1

Physical Therapy- Journal of the APTA- June 2009, Volume 89, Issue 6

Physical Therapy- Journal of the APTA- July 2009, Volume 89, Issue 7

Physical Therapy- Journal of the APTA- August 2009, Volume 89, Issue 8

Physical Therapy- Journal of the APTA- Feburary 2009, Volume 89, Issue 2

Physical Therapy- Journal of the APTA- March 2009, Volume 89, Issue 3

Physical Therapy- Journal of the APTA- November 2009, Volume 89, Issue 11

Physical Therapy- Journal of the APTA- May 2009, Volume 89, Issue 5

Physical Therapy- Journal of the APTA- December 2009, Volume 89, Issue 12

Physical Therapy- Journal of the APTA- April 2009, Volume 89, Issue 4

Physical Therapy- Journal of the APTA- September 2009, Volume 89, Issue 9

Physical Therapy- Journal of the APTA- October 2009, Volume 89, Issue 10

Journal of Neurologic Physical Therapy (March 2010, Volume 34, Issue 1)

Manual Therapy Journal - Volume 11, Issue 1, Pages 1-90 (February 2006)

Manual Therapy Journal - Volume 13, Issue 1, Pages 1-90 (February 2008)

sports medicine Volume 40 Issue 1 January 2010

Reflections Journal Issue 1

Israel Journal of Mathematics, Volume 1, Issue 1 (1963)

Journal of Semantics, Volume 1, Issue 1, 1982

Microsoft Architects Journal: Journal 1 (January, 2004)

Applied Linguistics, Volume 31, issue 1, 2010

The Perl Journal (January)

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