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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 [with consumer summary]
Rhon DI, Boyles RB, Cleland JA
Annals of Internal Medicine 2014 Aug 5;161(3):161-169
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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% versus 37%) and required additional steroid injections (38% versus 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.

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