An interventional study of Acupuncture and Sham treatment in Temporomandibular Disorders (TMD), sponsored by Beijing Hospital of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Beijing Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 48 is close to the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Beijing Hospital of Traditional Chinese Medicine is the lead sponsor of 22 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
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.
Visual Analog Scale
The VAS is a self-administered instrument, ranging from 0 (no pain at all) to 10 (worst imaginable pain).
Time frame: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
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).
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
Effective response rate is revealed as proportion of participants whose average VAS scores decrease by at least 30% or 50%.
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
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).
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
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.
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
JFLS-20 is an organ-specific instrument that assesses the functional status of the masticatory system. It includes 20 items across 3 domains, with responses for each functional item ranging from 0 (no limitation) to 10 (severe limitation).
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
DASS-21 is used to measure emotional states. It consists of three independent subscales with a total of 21 items, with seven items each for depression, anxiety, and stress subscales. Each item is assessed using a Likert scale (0 = did not apply to me at all, 3 = applied to me very much, or most of the time). A higher score indicates greater severity of emotional distress
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
PSQI evaluates participants' sleep quality and disturbances over the preceding month. It consists of 19 items, including 4 open questions and 15 Likert-type questions, each scored on a scale from 0 to 3. These 19 items are organized into seven component scores. Higher scores reflect more severe sleep disturbances, with a cutoff score of 5 indicating poor sleep quality.
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
PPT will be measured at five points: masseter, temporalis, sternocleidomastoid, trapezius, and TMJ, using a pressure algometer (Somedic AB, Sweden). Each measurement point will be assessed three times, with a two-minute interval between measurements. The lowest value from each point will be recorded by a trained assessor, and the final value will represent the average of the three measurements. Lower PPT values indicate greater pain sensitivity.
Time frame: From baseline (week 0) to the end of treatment (week 4)
Plan to share: No
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders →
Beijing Hospital of Traditional Chinese Medicine