Clinical trial NCT06738667: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders (TMD)
Keywords: Temporomandibular disorders
Acupuncture
Magnetic resonance imaging
Randomized controlled trial
Protocol
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
Secondary outcomes:
measure: Magnetic Resonance Imaging
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
measure: Effective response rate
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
measure: Jaw Opening and Movement
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
measure: Graded Chronic Pain Scale
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
measure: Jaw Function Limitation Scale-20
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
measure: Depression Anxiety and Stress Scale-21
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
measure: Pittsburgh Sleep Quality Index
timeFrame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
measure: Pressure Pain Threshold
timeFrame: From baseline (week 0) to the end of treatment (week 4)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
state: Beijing
Study officials:
References: