Effect of Adjunctive Intraoral Balance Appliance in the Usual Care of Patients with Chronic Temporomandibular Joint Disorders using Korean Medicine: Study Protocol for a Randomized Controlled Trial

IntroductionTemporomandibular disorders (TMD) are a group of conditions that affect the temporomandibular joint, masticatory muscles, and associated structures, often leading to pain, dysfunction, and a significant impact on quality of life. Epidemiological studies have estimated that up to 75% of the population in the United States exhibit at least one sign of TMD. Although conservative treatments such as acupuncture and occlusal splints have been recommended, evidence for their effectiveness remains inconclusive, and the combined effects of these interventions are not well understood. This study aims to compare the efficacy of an intraoral balance appliance (IBA) combined with standard Korean medicine care versus Korean medicine care alone in patients with chronic, painful TMD with myalgia. Materials and MethodsA single-center, two-arm, parallel, evaluator-blinded, randomized controlled trial (RCT) with a 1:1 allocation ratio will be designed to test the interventions. Seventy-six TMD patients with myalgia will be recruited and randomized. The Interventions will include manual acupuncture and physical therapy in both groups, with the addition of IBA in the treatment group. DiscussionThe outcomes will be measured using various scales such as the numeric rating scale for pain and bothersomeness, jaw functional limitation scale, and quality of life indicators. ConclusionThe trial is expected to provide evidence of the efficacy of combining the usual Korean medicine care and IBA in managing chronic TMD myalgia. Despite certain limitations such as the short intervention period and lack of standardized splint therapy, this RCT will contribute valuable data to guide the future treatment of TMD with myalgia. Trial registrationClinical Research information Service (CRiS) ID: KCT0008906. Registered on October 30, 2023