Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Randomized controlled Clinical Trial

IntroductionTemporomandibular joint (TMJ) disorders are associated with severe pain and functional impairment. Although thread embedding acupuncture (TEA) is commonly used for the management of temporomandibular disorders (TMD) at clinical sites, evidence supporting its use remains insufficient. This study aimed to evaluate the efficacy, safety, and cost-effectiveness of TEA for the treatment of chronic TMJ disorders. MethodsThis randomized, assessor-blinded, controlled clinical trial included 76 patients with chronic TMD. Participants will be randomly allocated to either the TEA or the usual care group. The TEA group will receive treatment administered at eight bilateral predefined acupoints for six weeks. The usual care group will receive transcutaneous electrical nerve stimulation (TENS) and infrared therapy. The primary outcome was average pain intensity measured using the Visual Analog Scale (VAS). The secondary outcomes will include maximum pain intensity (VAS), vertical TMJ opening, Graded Chronic Pain 2.0, Jaw Functional Limitation Scale-20, Patient Global Impression of Change, EuroQol 5-Dimension 5-level (EQ-5D-5L), adverse events, and medical costs for economic evaluation. DiscussionThis study provides evidence for the efficacy and safety of TEA for chronic TMJ disorders and explores its potential as a cost-effective treatment. Trial registrationThis study was registered with the Clinical Research Information Service of the Republic of Korea (Registration Number: KCT0009946).