To compare the efficacy of combination therapy (hydrodilatation and subdeltoid bursa injection with corticosteroid, mobilization, and physical therapy (PT)) with that of PT alone for treating frozen shoulder. A prospective, 2-arm parallel, single-blinded, randomized controlled trial. Rehabilitation clinic of a private academic hospital. Patients (n = 70) with frozen shoulder (freezing stage). Participants (n = 35) in the combination group underwent hydrodilatation and subdeltoid bursa injection with corticosteroid twice, mobilization, and usual-care PT for 8 weeks; participants (n = 35) in the PT group received only the usual-care PT for 8 weeks. The Shoulder Pain and Disability Index (SPADI) was the primary outcome measure. The secondary outcome measures were pain scores on a visual analog scale, range of motion (ROM), the Shoulder Disability Questionnaire (SDQ), quality of life (evaluated using the 36-item Short-Form Health Survey (SF-36)), and self-assessment of the treatment effect. Compared with the PT group, the combination group had significantly better pain (during activity), SPADI, SDQ, active and passive ROM, and self-assessment scores (all p < 0.001) as well as scores on some parts of the SF-36 (physical function and bodily pain, p < 0.05). Between-group differences were significant at the 1-, 2-, 4-, and 6-month follow-ups. A combination of hydrodilatation (with corticosteroid), bursal corticosteroid injection, and joint mobilization with PT was superior to PT alone for treating frozen shoulder, and the effects persisted for at least 6 months.

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