Efficacy, Safety and Cost-Effectiveness of Thread-Embedding Acupuncture for Adhesive Capsulitis (Frozen Shoulder): A Study Protocol for a Multicenter, Randomized, Patient-Assessor Blinded, Controlled Trial

Bonhyuk Goo,1,* Yeon-Cheol Park,2,* Eunseok Kim,3,4 Won-Suk Sung,5 Eun-Jung Kim,6 Jung-Hyun Kim,1 Byung-Kwan Seo,2 Yong-Hyeon Baek2 1Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea; 2Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; 3Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea; 4Department of Acupuncture and Moxibustion Medicine, Pusan National University Korean Medicine Hospital, Yangsan-si, Republic of Korea; 5Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea; 6Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University, Gyeongju, Republic of Korea*These authors contributed equally to this workCorrespondence: Yong-Hyeon Baek, Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea, Tel +82 2 440 6099, Fax +82 2 440 7143, Email byhacu@khu.ac.krBackground: The aim of the present study is to confirm the efficacy, safety, and cost-effectiveness of thread-embedding acupuncture (TEA) in the treatment of adhesive capsulitis (AC).Methods: This is a randomized, sham-controlled, patient-assessor blinded trial with two parallel arms in a 1:1 ratio. A total of 160 participants with AC, also known as frozen shoulder, will be recruited and screened according to the eligibility criteria. Those who meet the eligibility criteria will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive either real TEA or thread-removed STEA treatment on nine acupoints once a week for 8 weeks while being blinded to the intervention. The shoulder pain and disability index will be evaluated as a primary outcome measure. In addition, a 100-mm pain visual analogue scale, rotator cuff quality of life scale, European Quality of Life 5-dimension 5-level scale, treatment satisfaction, safety assessment, and economic evaluation will be assessed as secondary outcome measures. Outcome assessments will be conducted for a total of 24 weeks, including a treatment period of 8 weeks and follow-up of 16 weeks, according to the schedule.Discussion: The results of this trial will provide a clinical basis for the efficacy, safety and cost-effectiveness of TEA in the treatment of patients with AC.Trial Registration Number: KCT0005920 (Clinical Research Information Service of the Republic of Korea). Registered on 22 February 2021.Keywords: thread-embedding acupuncture, adhesive capsulitis, frozen shoulder, randomized controlled trial, protocol