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NCT06738667 | NOT YET RECRUITING | Temporomandibular Disorders (TMD)

Acupuncture for Painful Temporomandibular Disorder
Sponsor:

Beijing Hospital of Traditional Chinese Medicine

Information provided by (Responsible Party):

Underneath

Brief 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.

Condition or disease

Temporomandibular Disorders (TMD)

Intervention/treatment

Acupuncture

Sham treatment

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Study on Imaging Characteristics and Predictive Radiology of Brain Network Regulation by Acupuncture in Patients with Painful Temporomandibular Disorders
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Acupuncture for Painful Temporomandibular Disorder

Location Details

NCT06738667

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Beijing

Beijing Hospital of Traditional Chinese Medicine

Beijing, Beijing, China, 100010