Thread-Embedding Acupuncture for the Treatment of Shoulder Instability: Protocol for a Randomized, Controlled, Patient-Assessor Blinded Pilot Study.

Abstract

PurposeThis study aims to determine the feasibility of thread-embedding acupuncture (TEA) for the treatment of shoulder instability.Patients and MethodsThis is a patient-assessor blinded, randomized, sham-controlled trial with two parallel arms. A total of 40 patients with shoulder instability aged between 13 and 43 years will be recruited and screened using set inclusion and exclusion criteria. After screening, they will be randomly allocated to the TEA or sham TEA group. Patients in both groups will then receive TEA or sham TEA treatment on six acupoints once a week for 8 weeks, which will be followed by additional follow-up assessments at 4 and 8 weeks after the end of treatment. Changes in shoulder pain and disability will be assessed as the primary outcome, whereas 100-mm pain visual analogue scale, shoulder range of motion, rotator cuff quality of life index, EuroQol 5-dimension 5-levels, treatment satisfaction, economic evaluation, and safety will all be measured as secondary outcomes of the study. Outcome assessment will be conducted at baseline and at 4, 8, and 16 weeks after screening.ConclusionThe results from this trial will help to design further clinical trials on the efficacy, safety, and cost-effectiveness of performing TEA for shoulder instability.Trial Registration NumberKCT0005921 (Clinical Research Information Service of the Republic of Korea).