Acupuncture for Painful Temporomandibular Disorder

Official title

Study on Imaging Characteristics and Predictive Radiology of Brain Network Regulation by Acupuncture in Patients with Painful Temporomandibular Disorders

Overview

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.

Interventions

• Other 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
• 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 t

Primary outcome measures

• Visual Analog Scale [Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)]

Secondary outcome measures (8)

• Magnetic Resonance Imaging [Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)]
• Effective response rate [Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)]
• Jaw Opening and Movement [Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)]
• Graded Chronic Pain Scale [Time frame: 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 [Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)]
• Depression Anxiety and Stress Scale-21 [Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)]
• Pittsburgh Sleep Quality Index [Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)]
• Pressure Pain Threshold [Time frame: From baseline (week 0) to the end of treatment (week 4)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Hospital of Traditional Chinese Medicine — Beijing

Identifiers

NCT: NCT06738667 · SL-2024BL02-100-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗