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Clinical Trials in China / NCT06738667
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Acupuncture for Painful Temporomandibular Disorder

NCT06738667 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Hospital of Traditional Chinese Medicine
Phase
Not applicable
Started
2025-06-01
Last updated
2024-12-18

Condition(s) studied

Temporomandibular Disorders (TMD)

Investigational drug(s) / intervention(s)

AcupunctureSham treatment

Acupuncture: 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). Participants will lie supine, and the skin will be sterilized. Sterile stainless-steel needles (0.25 mm diameter, 40 mm length) will be inserted using a guide device and a self-adhesive pad. Needles will be manipulated for at least 10 seconds to induce Deqi. Participants will receive 30 minutes of acupuncture for twelve sessions (3 per week for 4 weeks).

Sham treatment: The Park Sham device will be used for the sham acupuncture group. To maintain blinding, the acupuncture ritual will be identical in both groups, with the following exceptions: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Hospital of Traditional Chinese Medicine Beijing Beijing Municipality

More Beijing Hospital of Traditional Chinese Medicine trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06738667 on ClinicalTrials.gov ↗ ← All trials in China