Temporomandibular disorders (TMDs) are a group of conditions affecting the temporomandibular joint (TMJ), 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 USA exhibits 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 evaluate the efficacy of an intraoral balance appliance (IBA) combined with standard Korean medicine care, compared to Korean medicine care alone, in patients with chronic, painful TMD with myalgia.

A single-centre, two-arm, parallel, practitioner-blinded and evaluator-blinded, randomised controlled trial with a 1:1 allocation ratio will be designed to test the interventions. 76 patients with TMD with myalgia will be recruited and randomised. The interventions will include manual acupuncture and physical therapy for both groups, with the addition of IBA in the treatment group for 3 weeks. The primary outcomes of the study will be the Numeric Rating Scale (NRS) for pain and discomfort at the final visit at week 4. Secondary outcomes will include overall functional assessment of the TMJ using several scales, as well as evaluations of quality of life, patient satisfaction and AEs.

The recruitment started on 18 July 2024, and 37 patients were included as of 8 July 2025.

Ethical approval is obtained from the Kyung Hee University Korean Medicine Hospital Institutional Review Board (IRB number: KOMCIRB 2023-06-001). The result from this study will be actively disseminated through manuscript publications and conference presentations.

The protocol was registered with the Clinical Research Information Service (CRiS), Republic of Korea, on 30 October 2023, CRiS number KCT0008906 prior to the initiation of the study, and was revised on 7 July 2025 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=30270&search_page=M&search_lang=&class_yn=).

Falls are common causes of disability, reduced disability-adjusted life years and death in older adults. Balance deficits and cognitive impairment are common causes of falls. Dual-task training is a new strategy that can potentially improve balance and cognitive function, leading to decreased falls. The effectiveness and cost-effectiveness of self-administered dual-task (sDT) training to improve balance and prevent falls is not known. We developed sDT training combining physical and cognitive tasks to improve balance and reduce falls. The proposed randomised controlled trial (RCT) with economic evaluation is to test the effectiveness and cost-effectiveness of the sDT compared with self-administered single-task training (sST) in this population.

In this RCT, we will recruit 190 community-dwelling older adults with a history of at least one fall over the last 6 months from 11 elderly centres. The older adults will be randomly assigned to the sDT (n=95) and sST groups (n=95). Each group will be offered in six training workshops to teach the participants either sDT or sST depending on the group allocation. Each workshop will last an hour and will be held once every 2 weeks for 3 months. Besides, the participants will be instructed to repeat the exercises at home two times weekly for 3 months. Following the intervention phase, the participants will continue unsupervised home-based exercises for 6 months. Assessments will be performed before, after and 6 months after completing the intervention. A fall calendar and cost diary will be provided to each older adult to record the number of falls and fall-related costs during and after the intervention to assess fall incidence and cost-effectiveness. Effectiveness will be assessed using a negative binomial regression model following the intention-to-treat principle for falls and a linear mixed model for the additional measure and cost-effectiveness using a Markov model.

This study has ethical approval from the PolyU Institutional Review Board for conducting research on human subjects (Ref: HSEARS20210322005). The results will be disseminated through seminars for individuals and health practitioners, international conferences and published in peer-reviewed journals.

NCT05533333.