What does this research mean for the field?

Temporomandibular joint balancing therapy (TBT) is a potentially effective treatment for temporomandibular joint disorders (TMD). Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.ESTABLISHES_NEW_DIRECTION.

What question did this study set out to answer?

This study aims to evaluate the efficacy, safety, and cost-effectiveness of temporomandibular joint balancing therapy for TMD.

March 14, 2026Open Access

The efficacy, safety, and cost-effectiveness of TMJ balancing therapy for temporomandibular joint disorder: study protocol for a randomized controlled trial

Key Points

This study aims to evaluate the efficacy, safety, and cost-effectiveness of temporomandibular joint balancing therapy for TMD.
Single-center, randomized, assessor-blinded, parallel-group clinical trial
30 participants aged 19 to 70 with chronic TMD randomly assigned to TBT or TENS
Both interventions administered twice a week for 6 weeks
Primary outcome: mean change in TMD pain measured by VAS at 6 weeks
Secondary outcomes include various pain and quality of life measures as well as economic evaluations
Expected improvement in TMD pain and function
Comparative analysis of TBT and TENS effectiveness
Assessment of cost-effectiveness demonstrated by ICER

Abstract

Temporomandibular joint disorders (TMD) are common musculoskeletal conditions affecting the masticatory system, leading to pain and functional limitations. Despite various conventional treatments, parts of the 2021 Korean Medicine Standard Clinical Practice Guidelines for TMD remain unaddressed due to insufficient supporting evidence for certain modalities like intraoral balancing appliances. This study aims to investigate a novel approach, temporomandibular joint balancing therapy (TBT), as a potential effective treatment. This will be a single-center, randomized, assessor-blinded, parallel-group clinical trial. A total of 30 eligible participants aged 19 to 70 years with chronic TMD (VAS ≥ 40 mm for ≥ 3 months) will be randomized 1:1 to either the experimental group (TBT) or the control group (Transcutaneous Electrical Nerve Stimulation, TENS). Both interventions will be administered twice a week for 6 weeks (12 sessions). The primary outcome is the mean change in temporomandibular joint pain measured by the Visual Analog Scale (VAS, 100 mm) at 6 weeks compared to baseline. Secondary outcomes include worst TMD pain VAS, jaw range of motion (pain-free opening, maximum unassisted opening), Jaw Functional Limitation Scale (JFLS-8), DC/TMD Graded Chronic Pain Scale (GCPS 2.0), Treatment Expectancy Scale, Patient Global Impression of Change (PGIC), quality-adjusted life years (QALYs), EQ-5D, EQ-VAS, medical costs, lost productivity costs, and incremental cost-effectiveness ratio (ICER). Data will be collected at baseline, 6 weeks, and 10 weeks (for follow-up). Statistical analysis will compare outcomes between groups using appropriate methods, primarily intention-to-treat analysis. This study protocol details a randomized controlled trial designed to provide robust evidence on the efficacy, safety, and economic feasibility of TBT for TMD. The findings are expected to contribute to the evidence base for TMD management, potentially informing future clinical practice guidelines, particularly concerning the use of intraoral balancing appliances in Korean medicine. This trial was retrospectively registered with the CRIS (http://cris.nih.go.kr). Registry: https://cris.nih.go.kr/cris/search/detailSearch.do?seq=29064, trial registration number: KCT0010382, date of registration: 3 April 2025.

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