Effectiveness of Pharmacopuncture Therapy in Adhesive Capsulitis: a Study Protocol for a Pragmatic Randomized Controlled Trial

Background: Adhesive capsulitis is a progressive, idiopathic disorder that significantly impacts individuals' daily lives and increases their medical burden. Pharmacopuncture therapy, which combines acupuncture techniques with herbal medicine, involves injecting herbal extracts into specific acupoints. This study aims to determine the effectiveness and safety of pharmacopuncture therapy in comparison to physiotherapy (PT) for treating adhesive capsulitis. Methods: This research protocol outlines a two-arm, parallel, multi-center, pragmatic randomized controlled trial. Fifty participants will be randomly allocated to either the pharmacopuncture therapy or PT group, and they will receive 12 sessions of their respective therapies over a 6-week period. The primary outcome measure is the numeric rating scale for shoulder pain. Secondary outcomes include the visual analog scale score for shoulder pain, Shoulder Pain and Disability Index, Patients' Global Impression of Change score, Short Form-12 Health Survey Version 2 score, and EuroQol-5 Dimension. Statistical analysis will be conducted based on the intention-to-treat principle.Discussion: This trial may offer high-quality and reliable clinical evidence for evaluating the effectiveness and safety of pharmacopuncture therapy compared to PT in the treatment of adhesive capsulitis. Furthermore, this study will serve as a valuable guideline for practitioners when making clinical decisions and managing adhesive capsulitis.