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Original Research |

One-Year Outcome of Subacromial Corticosteroid Injection Compared With Manual Physical Therapy for the Management of the Unilateral Shoulder Impingement Syndrome: A Pragmatic Randomized TrialOne-Year Outcome of CSI and MPT for Management of SIS

Daniel I. Rhon, PT, DPT, DSc; Robert B. Boyles, PT, DSc; and Joshua A. Cleland, PT, PhD
[+] Article and Author Information

From Madigan Army Medical and University of Puget Sound, Tacoma, Washington, and Franklin Pierce University, Manchester, New Hampshire.

Disclaimer: The opinions and assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or Department of Defense.

Acknowledgment: The authors thank Dr. David Brown, sports medicine physician, who administered the CSIs in this trial.

Grant Support: By Cardon Rehabilitation Products through the American Academy of Orthopaedic Manual Physical Therapists.

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2199.

Reproducible Research Statement:Study protocol: Published and available (29). Statistical code: Available from Dr. Rhon (daniel.i.rhon.mil@mail.mil). Data set: Available after execution of a Cooperative Research and Development Agreement and Data Use Agreement with the appropriate Department of Defense regulatory agencies. Contact Dr. Rhon (daniel.i.rhon.mil@mail.mil) if interested.

Requests for Single Reprints: Daniel I. Rhon, PT, DPT, DSc, Center for the Intrepid, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX 78234; e-mail, daniel.i.rhon.mil@mail.mil.

Current Author Addresses: Dr. Rhon: Center for the Intrepid, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX 78234.

Dr. Boyles: University of Puget Sound, School of Physical Therapy, 1500 North Warner Street, Tacoma, WA 98416.

Dr. Cleland: Franklin Pierce University, Physical Therapy Program, 670 North Commercial Street, Suite 301, Manchester, NH 03101.

Author Contributions: Conception and design: D.I. Rhon, R.B. Boyles, J.A. Cleland.

Analysis and interpretation of the data: D.I. Rhon, R.B. Boyles, J.A. Cleland.

Drafting of the article: D.I. Rhon, R.B. Boyles, J.A. Cleland.

Critical revision of the article for important intellectual content: D.I. Rhon, R.B. Boyles, J.A. Cleland.

Final approval of the article: D.I. Rhon, R.B. Boyles, J.A. Cleland.

Provision of study materials or patients: D.I. Rhon, R.B. Boyles, J.A. Cleland.

Statistical expertise: D.I. Rhon.

Obtaining of funding: D.I. Rhon, J.A. Cleland.

Administrative, technical, or logistic support: D.I. Rhon, R.B. Boyles.

Collection and assembly of data: D.I. Rhon, R.B. Boyles.


Ann Intern Med. 2014;161(3):161-169. doi:10.7326/M13-2199
Text Size: A A A

Background: Corticosteroid injections (CSIs) and physical therapy are used to treat patients with the shoulder impingement syndrome (SIS) but have never been directly compared.

Objective: To compare the effectiveness of 2 common nonsurgical treatments for SIS.

Design: Randomized, single-blind, comparative-effectiveness, parallel-group trial. (ClinicalTrials.gov: NCT01190891)

Setting: Military hospital–based outpatient clinic in the United States.

Patients: 104 patients aged 18 to 65 years with unilateral SIS between June 2010 and March 2012.

Intervention: Random assignment into 2 groups: 40-mg triamcinolone acetonide subacromial CSI versus 6 sessions of manual physical therapy.

Measurements: The primary outcome was change in Shoulder Pain and Disability Index scores at 1 year. Secondary outcomes included the Global Rating of Change scores, the Numeric Pain Rating Scale scores, and 1-year health care use.

Results: Both groups demonstrated approximately 50% improvement in Shoulder Pain and Disability Index scores maintained through 1 year; however, the mean difference between groups was not significant (1.5% [95% CI, −6.3% to 9.4%]). Both groups showed improvements in Global Rating of Change scale and pain rating scores, but between-group differences in scores for the Global Rating of Change scale (0 [CI, −2 to 1]) and pain rating (0.4 [CI, −0.5 to 1.2]) were not significant. During the 1-year follow-up, patients receiving CSI had more SIS-related visits to their primary care provider (60% vs. 37%) and required additional steroid injections (38% vs. 20%), and 19% needed physical therapy. Transient pain from the CSI was the only adverse event reported.

Limitation: The study occurred at 1 center with patients referred to physical therapy.

Conclusion: Both groups experienced significant improvement. The manual physical therapy group used less 1-year SIS-related health care resources than the CSI group.

Primary Funding Source: Cardon Rehabilitation Products through the American Academy of Orthopaedic Manual Physical Therapists.

Figures

Grahic Jump Location
Figure 1.

Study flow diagram.

CSI = corticosteroid injection; MPT = manual physical therapy; SIS = shoulder impingement syndrome; SPADI = Shoulder Pain and Disability Index.

* 1 clinician performed the subacromial CSI.

† 2 clinicians performed MPT.

‡ Loss to follow-up was reported independently for each time point. It is possible that a patient missed 1 time point but then was followed up at a different time point. The primary outcome was measured at 1-y follow-up.

Grahic Jump Location
Grahic Jump Location
Figure 2.

Comparative effectiveness measured by changes in SPADI scores over time.

Mean effect estimates (95% CIs) from observed data. Overlapping error bars indicate that no significant difference was found between groups at any time point. CSI = corticosteroid injection; MPT = manual physical therapy; SPADI = Shoulder Pain and Disability Index.

Grahic Jump Location
Grahic Jump Location
Figure 3.

Relative risk for using additional health care resources.

CSI = corticosteroid injection; MPT = manual physical therapy; MRI = magnetic resonance imaging; PCP = primary care provider; PT = physical therapy.

* Significantly favors MPT.

Grahic Jump Location

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Comments

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Comment
Posted on August 22, 2014
Chris B. Leib
Pain Relief and Physical therapy
Conflict of Interest: None Declared
On the surface, Rhon et al’s1 thoughtful study demonstrates the effectiveness of both subacromial corticosteroid injection (CSI) and manual physical therapy (MPT) in treatment for shoulder impingement syndrome (SIS). However, several factors complicate the comparison of MPT to medical intervention and so perhaps limit the study’s otherwise valuable contribution:

1. The manual therapy approach used in this study was well described elsewhere2. In contrast, physical therapists in clinical practice typically assess the presence and quality of symptoms in relation to patient movement and position, not according to a pathoanatomical diagnosis as described here. Factors such as tissue stiffness/resistance, irritability to pressure, and joint/neuromuscular instability would be far more relevant when formulating a physical therapist’s diagnosis and appropriate intervention.
2. Manual physical therapists continually reassess and adjust treatment based on the patient’s symptomatic changes structured as a test/re-test model (get a baseline, do an intervention and then re-test the baseline to look for change). Test/re-test assessment has been validated3 and is the common thread linking many different approaches of assessment utilized by all types of physical therapists. This differs from a physician’s typical assessment and treatment, in that therapists spend a larger volume of time (generally 2-3x/week for at least 4 weeks) observing patients move and assessing their response to various non-invasive interventions.
3. The patient education process may not have been sufficiently emphasized in this study. Many shoulder musculoskeletal conditions have high recurrence rates4, particularly when the mechanism of injury is progressive in nature and thought to be from repetitive overuse of the injured area. In these frequent cases, abolition and recurrence of symptoms may simply be part of the natural history of the condition; short-term pain control and improved functionality would not be the ultimate goal of intervention. Physical therapists educate their patients to become their own “self-assessors” and learn how and when to use appropriate self-treatment techniques as developed through the assessment approach utilized when deciding on appropriate manual techniques.
4. Finally, CSI and MPT often work in synergy: CSI decreases inflammation and MPT decreases the mechanical stress that may have caused the symptoms in the first place. Including a third group that received both interventions might have allowed for a more clinically relevant comparison.

References:
1. Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management ofthe unilateral shoulder impingement syndrome. A pragmatic randomized trial.Ann Intern Med. 2014;161:161-9. doi:10.7326/M13-2199
2. Rhon DI, Boyles RE, Cleland JA, Brown DL. A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial. BMJ Open. 2011;1(2):e000137.
3. Cook CE, Showalter C, Kabbaz V, O'halloran B. Can a within/between-session change in pain during reassessment predict outcome using a manual therapy intervention in patients with mechanical low back pain?. Man Ther. 2012;17(4):325-9.
4. Luime JJ, Koes BW, Miedem HS, Verhaar JA, Burdorf A. High incidence and recurrence of shoulder and neck pain in nursing home employees was demonstrated during a 2-year follow-up. J Clin Epidemiol. 2005;58(4):407-13.

Response from Authors
Posted on September 12, 2014
Daniel I Rhon, PT, DPT, DSc Robert Boyles, PT, DSc Joshua Cleland, PT, PhD
Madigan Army Medical Center
Conflict of Interest: None Declared
We would like to thank Mr. Lieb for his interest in our study, and the list of factors he feels may confound the direct comparison of the 2 treatments for shoulder impingement syndrome (SIS); corticosteroid injection (CSI) and manual physical therapy (MPT).1 We appreciate the opportunity to address each of these comments.
1. As stated in our original report, one of the limitations is the lack of consensus on diagnostic criteria for SIS. In order to study a homogenous group of patients, we enrolled those with similar presentation and functional limitations. Thus the inclusion criteria. What Mr. Lieb suggested for evaluation is exactly what was done. As part of the assessment during treatment, all the factors mentioned were certainly assessed by the treating physical therapists (stiffness, irritability to pressure, etc). This was not a pathoanatomic directed evaluation nor intervention, rather an impairment based model based on the previously stated criteria.
2. Yes, we agree that patient exposure is typically greater with a physical therapist based on the nature of the interactions.
3. Yes, we agree that the goal of healthcare providers in general should be to get patients to a place of effective self-management. We would imagine this to be true whether it is a musculoskeletal complaint or long-term management of diabetes or chronic obstructive pulmonary disorders.
4. We do not refute the potential synergestic value of these interventions.

We do not disagree with any of these statements. However, when evaluating the question driving this study, we do not feel that these factors complicate the comparison. Our goal with this pragmatic trial was to compare 2 intervention approaches for the management of SIS and not to compare how 2 different types of medical providers would approach the management of the same patient. It may seem subtle but is an important difference in our minds. To answer our question, we needed to replicate usual practice as much as possible. Thorpe and colleagues2 described 10 domains to help evaluate the pragmatic nature of a trial. When establishing the comparison treatment, pragmatic trials should employ “usual practice, or the best alternative management strategy”. Treweek3 argues that clinical trials should be designed to produce results that are more widely applicable. We chose these 2 treatments because they represent 2 common treatment options that patients are provided in usual practice.

1. Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Annals of internal medicine. 2014;161:161-169.
2. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of clinical epidemiology. 2009;62:464-475.
3. Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009;10:37.

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Summary for Patients

Corticosteroid Injections Versus Manual Physical Therapy for Treatment of the Shoulder Impingement Syndrome

The full report is titled “One-Year Outcome of Subacromial CorticosterToid Injection Compared With Manual Physical Therapy for the Management of the Unilateral Shoulder Impingement Syndrome. A Pragmatic Randomized Trial.” It is in the 5 August 2014 issue of Annals of Internal Medicine (volume 161, pages 161-169). The authors are D.I. Rhon, R.B. Boyles, and J.A. Cleland.

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