Acupuncture for Painful Temporomandibular Disorder

NCT06738667 | Not Yet Recruiting DMC

• 1 other identifier: SL-2024BL02-100-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders (TMD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The VAS is a self-administered instrument, ranging from 0 (no pain at all) to 10 (worst imaginable pain).

  From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)

Secondary Outcomes (8)

• Magnetic Resonance Imaging

  From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)

• Effective response rate

  From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)

• Jaw Opening and Movement

  From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)

• Graded Chronic Pain Scale

  From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)

• Jaw Function Limitation Scale-20

  From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)

Study Arms (2)

acupuncture

EXPERIMENTAL

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).

Other: Acupuncture

sham acupuncture

SHAM COMPARATOR

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.

Other: Sham treatment

Interventions

Acupuncture 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).

acupuncture

Sham treatment 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.

sham acupuncture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• Having suffered from pain of dental origin, trauma, sinus pathology, neuropathic origin, inflammatory systemic diseases and cancer;
• Having a history of rheumatoid arthritis;
• Presence of mental illness or substance abuse;
• Pregnant, lactating, or planning to become pregnant;
• Participants with common contra-indications for MRI such as claustrophobia or metal implants.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Bin Li, Dr

CONTACT

0086-18910781852; libin@bjzhongyi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 18, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)