Clinical research on the clinical effectiveness and cost-effectiveness of Chuna manual therapy for temporomandibular disorder: A study protocol for a multicenter randomized controlled trial

Introduction Chuna manual therapy (CMT), one of the therapeutic modalities of Korean Medicine which is a kind of manual therapies, is well known among Korean Medicine doctors for the treatment of TMD but the evidence for the effect of CMT is insufficient. Therefore, this trial is designed to propose a protocol to investigate the efficacy and economic efficiency of CMT on TMD, compared to usual care (UC). Methods This trial is a prospective, assessor-blinded, two-arm parallel multicenter randomized controlled trial. Eighty patients with temporomandibular disorder, with numeric rating scale (NRS) above 4, will be randomly assigned to either the CMT or the UC group, with a 1:1 ratio. Participants will be recruited by five Korean Medicine hospitals. Participants will be treated eight times for 4 weeks, and will be assessed for pain, range of motion, depressive symptoms, and quality of life. Adverse events will also be reported. To evaluate the cost-effectiveness, medical consumption data (quality of life questionnaire) will be used to assess indices such as the Quality Adjusted Life Year. Discussion There were randomized controlled trials (RCTs) investigating the effect of CMT for TMD, however, evidence is evaluated as “Low”. For this reason, this trial was designed as a high-quality RCT protocol. Conclusion We expect that this trial will contribute new knowledge on the effects of CMT for TMD, so that an economically efficient way of treatment could be developed and standardized, providing more populations with the benefits of an effective and economic treatment for TMD.