Journal of Pain Research (Oct 2022)
Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial
Abstract
Jung-Hyun Kim,1 Dahae Kang,2 Koh-Woon Kim,3 Sang-Soo Nam,1,* Bonhyuk Goo1,* 1Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea; 2Industry-Academic Cooperation Foundation, Kyung Hee University, Seoul, Republic of Korea; 3Department of Korean Rehabilitation Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea*These authors contributed equally to this workCorrespondence: Sang-Soo Nam; Bonhyuk Goo, Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea, Tel +82 2 440 7135 ; +82 2 440 6099, Fax +82 2 440 7143 ; +82 2 440 6074, Email [email protected]; [email protected]: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lacking. This pilot trial will explore the feasibility of a confirmatory randomized controlled trial (RCT) by considering the efficacy, safety, and cost-effectiveness of TEA to address pain, function, and quality of life in patients with TMD.Methods: This randomized, assessor-blinded, controlled trial will include two parallel arms. Thirty patients with TMD and temporomandibular joint pain more severe than 40 mm on the 100-mm visual analog scale (VAS) and aged 19– 70 years will be recruited and randomly allocated to either TEA or usual care groups. The TEA group will receive treatment at 14 predefined acupoints once weekly for 4 weeks. The usual care group will receive physical therapy consisting of transcutaneous electrical nerve stimulation and infrared therapy. The average VAS score over the last week for temporomandibular pain after four sessions will be assessed as the primary outcome. Furthermore, maximum pain VAS, vertical opening movement, Graded Chronic Pain version 2, Jaw Functional Limitation Scale 20, Patient Global Impression of Change, Korean version of Beck’s Depression Index, Short Form-12 Health Survey, EuroQol 5-Dimension 5-level, treatment expectation, rescue medication consumption, adverse events, and medical costs for economic evaluation will be measured and analyzed as secondary outcomes during four follow-up visits and after the termination of all sessions.Conclusion: The results of this trial will help evaluate the feasibility of a confirmatory RCT considering efficacy, safety, and cost-effectiveness and verify the effect size required to determine an appropriate sample size.Trial Registration Number: KCT0007421.Keywords: jaw pain, visual analogue scale, vertical mouth opening, Jaw Functional Limitation Scale, polydioxanone thread, DC/TMD
