Daoyin Exercise Therapy for the Treatment of Shoulder Pain: Protocol for a Multicenter, Randomized, Single-blinded, Pragmatic Controlled Trial

Objectives: The aim of this clinical trial is to investigate the therapeutic benefit, safety, and cost-effectiveness of Daoyin Exercise Therapy (DET) combined with Acupuncture (AT) for unilateral shoulder pain.Methods: This study is a multicenter, open-label, single-blinded (assessor-blinded), pragmatic randomized controlled trial with two parallel arms. Eighty-two participants with unilateral shoulder pain will be randomly assigned in a 1:1 ratio to either the DET plus AT intervention group (n=41) or the AT control group (n=41). Participants will receive 12 treatment sessions over 6 weeks (twice a week). A follow-up will be conducted via telephone four weeks after the final visit. The primary outcome will be the Shoulder Pain and Disability Index (SPADI). Secondary outcomes will be the Numeric Rating Scale (NRS), Active Range of Motion (AROM), EuroQol-5 Dimensions-5 Level (EQ-5D-5L), and EuroQol visual analogue scale (EQ-VAS). Safety will be assessed at every visit, and economic evaluation will be conducted as a mixed-methods approach.Results: The results of each of the indices will be presented as tables or figures, and the findings will be published in a peer-reviewed journal.Conclusions: This study may support the use of DET as a viable adjunctive option for managing shoulder pain and may inform clinical standardization and health policy development.