Temporomandibular Disorders (TMD)NCT06738667
Acupuncture for Painful Temporomandibular Disorder
A study testing Acupuncture in people with Temporomandibular Disorders (TMD), run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100010
Bin Li, MD, 0086-18910781852, libin@bjzhongyi.com
About this study
Official title: Study on Imaging Characteristics and Predictive Radiology of Brain Network Regulation by Acupuncture in Patients with Painful Temporomandibular Disorders
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.
Read the 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.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Acupuncture, Sham treatment
- Keywords
- Temporomandibular disorders, Acupuncture, Magnetic resonance imaging, Randomized controlled trial, Protocol
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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).
Sham treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The VAS is a self-administered instrument, ranging from 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 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
(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).
Measured: 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%.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: From baseline (week 0) to the end of treatment (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li bin, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738667
- Sponsor's protocol ID
- SL-2024BL02-100-02
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Imaging Characteristics and Predictive Radiology of Brain Network Regulation by Acupuncture in Patients with Painful Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT06738667
- Acronym / sponsor ID
- SL-2024BL02-100-02
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Temporomandibular disorders, Acupuncture, Magnetic resonance imaging, Randomized controlled trial, Protocol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Other: AcupuncturePatients 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). |
| sham acupuncture | Sham comparator | Other: Sham treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupuncturePatients 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). | Other | acupuncture |
| Sham treatmentThe 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. | Other | sham acupuncture |
Primary outcome
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)
The VAS is a self-administered instrument, ranging from 0 (no pain at all) to 10 (worst imaginable pain).
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Temporomandibular Disorders (TMD), run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Li, Dr (0086-18910781852, libin@bjzhongyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.