ABSTRACT

Introduction Temporomandibular 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 Methods A 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.

Discussion The 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.

Conclusion The 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 registration Clinical Research information Service (CRiS) ID: KCT0008906. Registered on October 30, 2023

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

Clinical Research information Service (CRiS) ID: KCT0008906

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval was obtained from the Institutional Review Board of Kyung Hee University Korean Medicine Hospital Institutional Review Board (IRB number: KOMCIRB 2023-06-001)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

AbbreviationsAEAdverse eventANCOVAAnalysis of covarianceCONSORTConsolidated standards of reporting trialsCRiSClinical Research information ServiceDC/TMDDiagnostic criteria for temporomandibular disorderseCRFElectronic case report formEQ-5D-5L5-Level EuroQol-5 dimensionGCPSGraded chronic pain scaleIBAIntraoral balance applianceIRBInstitutional review boardJFLSJaw functional limitation scaleKMDKorean medicine doctorNCKMNational Clearinghouse for Korean MedicineNRSNumeric rating scalePHQ-9Patient health questionnaire-9PGICPatient global impression of changeSAESevere adverse eventSTRICTAStandards for reporting interventions in clinical trials of acupunctureTMDTemporomandibular joint disorderTMJTemporomandibular jointRM-ANOVARepeated measure analysis of varianceROMRange of motion