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

Background: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lac...

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Bibliographic Details
Published in:Journal of pain research 2022-01, Vol.15, p.3197-3207
Main Authors: Kim, Jung-Hyun, Kang, Dahae, Kim, Koh-Woon, Nam, Sang-Soo, Goo, Bonhyuk
Format: Article
Language:English
Subjects:
Acupuncture
Analysis
Anti-inflammatory agents
Benzodiazepines
Clinical trials
Cognition & reasoning
dc/tmd
Education
Evidence-based medicine
Hospitals
Informed consent
Jaw
jaw functional limitation scale
jaw pain
Medicine, Botanic
Medicine, Herbal
Nonsteroidal anti-inflammatory drugs
Pain
Patients
Physical therapy
polydioxanone thread
Quality of life
Study Protocol
Temporomandibular joint disorders
Transcutaneous electrical nerve stimulation-TENS
vertical mouth opening
visual analogue scale
Womens health
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Summary:Background: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lacking. This pilot trial will explore the feasibility of a confirmatory randomized controlled trial (RCT) by considering the efficacy, safety, and cost-effectiveness of TEA to address pain, function, and quality of life in patients with TMD. Methods: This randomized, assessor-blinded, controlled trial will include two parallel arms. Thirty patients with TMD and temporomandibular joint pain more severe than 40 mm on the 100-mm visual analog scale (VAS) and aged 19-70 years will be recruited and randomly allocated to either TEA or usual care groups. The TEA group will receive treatment at 14 predefined acupoints once weekly for 4 weeks. The usual care group will receive physical therapy consisting of transcutaneous electrical nerve stimulation and infrared therapy. The average VAS score over the last week for temporomandibular pain after four sessions will be assessed as the primary outcome. Furthermore, maximum pain VAS, vertical opening movement, Graded Chronic Pain version 2, Jaw Functional Limitation Scale 20, Patient Global Impression of Change, Korean version of Beck's Depression Index, Short Form-12 Health Survey, EuroQol 5-Dimension 5-level, treatment expectation, rescue medication consumption, adverse events, and medical costs for economic evaluation will be measured and analyzed as secondary outcomes during four follow-up visits and after the termination of all sessions. Conclusion: The results of this trial will help evaluate the feasibility of a confirmatory RCT considering efficacy, safety, and costeffectiveness and verify the effect size required to determine an appropriate sample size. Trial Registration Number: KCT0007421. Keywords: jaw pain, visual analogue scale, vertical mouth opening, Jaw Functional Limitation Scale, polydioxanone thread, DC/TMD
ISSN:1178-7090
1178-7090
DOI:10.2147/JPR.S383965