Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial

Area of Science:

• Integrative Medicine
• Pain Management
• Rheumatology

Background:

• Temporomandibular disorder (TMD) causes orofacial pain and functional issues.
• Thread embedding acupuncture (TEA) is clinically used for TMD, but lacks robust evidence.
• A pilot trial is needed to assess TEA's efficacy, safety, and cost-effectiveness for TMD.

Purpose of the Study:

• To evaluate the feasibility of a definitive randomized controlled trial (RCT) for TEA in TMD patients.
• To explore the efficacy, safety, and cost-effectiveness of TEA compared to usual care.
• To determine the effect size for sample size calculation in future RCTs.

Main Methods:

• A randomized, assessor-blinded, controlled trial with two parallel arms.
• Thirty patients with TMD and significant pain (VAS > 40mm) were recruited.
• Intervention: TEA at 14 acupoints weekly for 4 weeks vs. usual care (TENS, infrared therapy).

Main Results:

• Primary outcome: change in visual analog scale (VAS) for temporomandibular pain.
• Secondary outcomes: maximum pain, jaw function, quality of life, depression, adverse events, and costs.
• Data collected over 4 weeks of treatment and follow-up visits.

Conclusions:

• This trial will assess the feasibility of a larger RCT for TEA in TMD.
• It will provide preliminary data on TEA's efficacy, safety, and cost-effectiveness.
• Findings will guide sample size determination for future confirmatory trials.