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.
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.
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;
Parallel
Acupuncture
Other interventionPatients 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 treatment
Other interventionThe 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.
Visual Analog Scale
The VAS is a self-administered instrument, ranging from 0 (no pain at all) to 10 (worst imaginable pain).
Magnetic Resonance Imaging
(1) structural MRI (sMRI): voxel-based whole-brain voxel-mirrored homotopic connectivity (VMHC), cortical thickness, gray matter volume (GMV), white matter volume (WMV), total brain volume (TBV); (2) fMRI: independent component analysis (ICA)-based functional connectivity (FC), seed-based FC, amplitude of low-frequency fluctuation (ALFF), fractional ALFF, regional homogeneity (ReHo), degree centrality (DC); (3) DTI: mean diffusivity (MD), radial diffusivity (RD), axial diffusivity (AD), and fractional anisotropy (FA).
Effective response rate
Effective response rate is revealed as proportion of participants whose average VAS scores decrease by at least 30% or 50%.
Jaw Opening and Movement
It is an evaluation of physical function, including 6 items: pain-free jaw opening (mm), maximum unassisted jaw opening (mm), maximum assisted jaw opening (mm), left lateral movement (mm), right lateral movement (mm), and protrusion movement (mm).
Graded Chronic Pain Scale
GCPS assesses disability, pain intensity, and whether an individual can work due to pain. It comprises three items for pain intensity, four items for function, and one item for the number of days with pain. Each item is scored on a scale of 0-10, higher scores indicate greater pain.
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