Journal of Pain Research (Sep 2021)
Thread-Embedding Acupuncture for the Treatment of Shoulder Instability: Protocol for a Randomized, Controlled, Patient-Assessor Blinded Pilot Study
Abstract
Bonhyuk Goo,1 Yong-Hyeon Baek2 1Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, Gangdong-gu, Seoul, Republic of Korea; 2Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Dongdaemun-gu, Seoul, Republic of KoreaCorrespondence: Yong-Hyeon BaekDepartment of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of KoreaTel +82 2 440 6099Fax +82 2 440 7143Email [email protected]: This study aims to determine the feasibility of thread-embedding acupuncture (TEA) for the treatment of shoulder instability.Patients and Methods: This 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.Conclusion: The 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 Number: KCT0005921 (Clinical Research Information Service of the Republic of Korea).Keywords: thread-embedding acupuncture, shoulder instability, shoulder pain, pilot study, randomized controlled trial
