Effectiveness of manual therapy with pragmatic physiotherapy for rotator cuff-related shoulder pain: a pilot randomized clinical trial.

Introduction: Physiotherapy for rotator cuff-related shoulder pain (RCRSP) typically includes patient education and exercise prescription, with manual therapy used as an adjunct to exercise. This parallel two-arm non-inferiority pilot trial determined the feasibility of a full randomised clinical trial comparing pragmatic physiotherapy with manual therapy (MT Group) to pragmatic physiotherapy without manual therapy (NoMT Group) for RCRSP, and explored preliminary treatment effects on patient-reported outcomes. Methods: Sixty-eight participants with persistent RCRSP were randomised to MT or NoMT groups, receiving physiotherapy treatments over a 3-month period, with only the MT group receiving manual therapy. Feasibility outcomes were recruitment and retention rates, adherence, and intervention fidelity. Research outcome measures were patient-related outcomes at baseline, 3, and 6-month follow-up. Results: Of 239 volunteers completing the online screening questionnaire, 108 were physically screened, and 70 (65%) were allocated. After two withdrawals, 33 in the MT group and 35 in the NoMT group completed baseline assessment. Retention, adherence, and fidelity exceeded 80% for both groups. Median treatment sessions were 7 for the MT group and 6 for the NoMT group. In the MT group, glenohumeral joint, thoracic spine, and soft tissue mobilisations were commonly used. Delivery of patient education and exercise prescription was similar between groups. QuickDASH between-group mean differences were below the non-inferiority margin. Self-efficacy favoured the MT group at 6-month follow-up. Conclusion: Results support feasibility for a full trial. Strategies to improve participant diversity are required. Definitive outcomes require confirmation in a full trial.