Acupuncture for Painful Temporomandibular Disorder

NCT ID: NCT06738667

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular disorders; Acupuncture; Magnetic resonance imaging; Randomized controlled trial; Protocol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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 acupuncture

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.

Group Type: SHAM_COMPARATOR

Sham treatment

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Li bin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Bin Li, Dr

Role: CONTACT

Phone: 0086-18910781852

Email: libin@bjzhongyi.com

Facility Contacts

Bin Li, MD

Role: primary

Other Identifiers

SL-2024BL02-100-02

Identifier Type: -

Identifier Source: org_study_id