Acupuncture for Painful Temporomandibular Disorder

Beijing Hospital of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Temporomandibular Disorders (TMD)

Treatments: Other: Sham treatment; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06738667

SL-2024BL02-100-02

Details and patient eligibility

About

Temporomandibular disorder (TMD) is a common musculoskeletal pain condition affecting the jaw, and acupuncture is often used for treatment, though its neurological mechanisms are unclear. This study investigates the neural mechanisms of acupuncture in TMD using functional MRI (fMRI), structural MRI (sMRI), and diffusion tensor imaging (DTI), alongside machine learning to predict treatment outcomes. This study aims to enhance understanding of acupuncture's effects on TMD and improve personalized treatment approaches.

Full description

A randomized, single-blind, sham-controlled trial will enroll 48 patients, divided into acupuncture and sham acupuncture groups. The study will consist of a 1-week baseline, 4-week treatment, and 8-week follow-up period, with 30-minute sessions three times a week for 12 sessions. Primary outcomes include changes in Visual Analog Scale (VAS) scores at week 4, with secondary outcomes including VAS changes at week 8, jaw function, and scores on pain, sleep, and mental health scales. Multimodal MRI scans will assess brain changes at baseline, post-treatment, and follow-up. Our research is a randomized controlled trial (RCT) combining sMRI, fMRI, and DTI to explore the efficacy of acupuncture in TMD treatment, using multi-modal imaging to provide a comprehensive biological profile of TMD patients. Our study aims to (1) analyze brain structural and functional network changes post-acupuncture, explore the relationship between central imaging and clinical symptom changes, and (2) predict individual treatment outcomes for TMD.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Having a history of pain-related TMD for at least three months;
2. Aged between 18 and 70 years;
3. Voluntary participation in the trial with signed informed consent.

Exclusion criteria

1. Having received occlusal splint, injection therapy, acupuncture, biofeedback, transcutaneous nerve stimulation, or TMD-specific medication (e.g., corticosteroids, benzodiazepines, sedative hypnotics, muscle relaxants, opioids, antidepressants, or anticonvulsants) for managing facial pain within one month before the screening period;
2. Having suffered from pain of dental origin, trauma, sinus pathology, neuropathic origin, inflammatory systemic diseases and cancer;
3. Having a history of rheumatoid arthritis;
4. Presence of mental illness or substance abuse;
5. Pregnant, lactating, or planning to become pregnant;
6. Participants with common contra-indications for MRI such as claustrophobia or metal implants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

acupuncture

Experimental group

Description:

Patients in the acupuncture group will receive treatment at specified acupoints, performed by acupuncturists with at least five years of experience. The acupoints include bilateral Hegu (LI4), Yanglingquan (GB34), and affected-side Jiache (ST6), Xiaguan (ST7), and Tinggong (SI19).

Treatment:

Other: Acupuncture

sham acupuncture

Sham Comparator group

Description:

Patients in the sham group will receive noninvasive acupuncture at the same acupoints as the acupuncture group. Sham needles, which resemble real needles but are blunt and slide within their handles, will be applied using the Park Sham device, secured to the skin with a self-adhesive pad. The procedure of manipulation is the same as for acupuncture, but without Deqi.

Treatment:

Other: Sham treatment