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.
RCT Entities:
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.
Authors: Antonio Barile; Alice La Marra; Francesco Arrigoni; Silvia Mariani; Luigi Zugaro; Alessandra Splendiani; Ernesto Di Cesare; Alfonso Reginelli; Marcello Zappia; Luca Brunese; Ejona Duka; Giampaolo Carrafiello; Carlo Masciocchi Journal: Br J Radiol Date: 2016-07-07 Impact factor: 3.039