An interventional study of Low-Level Laser Acupuncture and Proprioceptive Training in Temporomandibular Disorders (TMD), TMJ Disorder and TMJ Pain, sponsored by En Chu Kong Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by En Chu Kong Hospital · Not applicable, Interventional, and Treatment
This study aims to improve clinical efficiency and effectiveness in treating Temporomandibular Disorders (TMD). The researchers will integrate machine learning technology with clinical examination data, CBCT, and MRI to identify the core underlying issues of each patient. Based on this precise, AI-assisted diagnosis, the study will implement a tailored treatment framework. The final goal is to develop predictive algorithms that can determine MRI necessity while ensuring that clinical interventions are highly targeted, efficient, and successful.
This study integrates machine learning with a clinical trial framework to optimize the evaluation and management of Temporomandibular Disorders (TMD). A total of 180 eligible participants are expected to be enrolled in the study. To ensure a homogenous sample, strict screening will be conducted using standardized psychometric scales; patients with significant psychosocial confounders (defined as GAD-7 ≥10, PHQ-9 ≥15, PHQ-15 ≥10, or PSQI >5) or comorbidities such as fibromyalgia, rheumatic autoimmune diseases, and trauma history will be excluded. Prior to treatment, baseline clinical examination, cone beam computed tomography (CBCT), and magnetic resonance imaging (MRI) data will be collected. All clinical data and longitudinal pre- and post-treatment MRI findings will be utilized to train advanced multi-modal diagnostic models; based on this foundational intelligence, predictive algorithms will then be developed to determine the necessity of an MRI scan using only clinical data and CBCT images. The enrolled participants will be divided by active maximum mouth opening into two subgroups (≤30 mm and >30 mm) and randomly assigned to three treatment arms: (1) Proprioceptive Training + Sham + LLLT (2 weeks of sham laser followed by 2 weeks of active laser acupuncture); (2) Proprioceptive Training + LLLT + LLLT (4 weeks of active laser acupuncture); and (3) Waiting List Control (receiving standard conservative care only).Proprioceptive training includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily. LLLT targets the Xiaguan (ST7), Yifeng (SJ17), and bilateral Fengchi (GB20) points once weekly. Assessments will be conducted biweekly during treatment, with final evaluation at 4 weeks and follow-ups at 1, 3, 6, 12, and 24 months post-treatment. Post-treatment MRI will be performed at the 4-week endpoint to evaluate objective intra-articular and perimuscular soft-tissue changes, correlating with improvements in pain resolution efficiency and mandibular range of motion recovery.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 180 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →En Chu Kong Hospital is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive proprioceptive training combined with low-level laser acupuncture. For the first 2 weeks, sham laser acupuncture (identical visual and auditory cues with no energy output) will be administered, followed by 2 weeks of active laser acupuncture. Proprioceptive training will be performed three times daily throughout the 4-week period.
Device: Low-Level Laser Acupuncture · Behavioral: Proprioceptive Training
Participants in this group will receive proprioceptive training combined with 4 weeks of active low-level laser acupuncture. Proprioceptive training will be performed three times daily, and active laser acupuncture will be administered once weekly for the entire 4-week period.
Device: Low-Level Laser Acupuncture · Behavioral: Proprioceptive Training
Participants assigned to this group will serve as a waiting list control and will receive standard conservative care, specifically utilizing a stabilization splint, during the 4-week trial period. They will not receive the experimental proprioceptive training or laser acupuncture protocols during this phase.
Device: Stabilization Splint Treatment
Laser acupuncture targets the Xiaguan (ST7), Yifeng (SJ17), and bilateral Fengchi (GB20) points once weekly. For the LLLT+LLLT group, active laser is given for 4 weeks. For the Sham+LLLT group, sham laser is given for the first 2 weeks followed by 2 weeks of active laser.
Also known as: Low-Level Laser, Laser Acupuncture
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
Also known as: Motor Control Training, Cranio-Cervico-Mandibular Malalignment / Dysfunction Training, Sensorimotor Training, Trigemino-Cervical System Rehabilitation
Standard conservative clinical care utilizing a hard acrylic flat-plane stabilization splint (centric stabilization splint) for TMD management. The splint is customized to provide even, bilateral occlusal contact in the musculoskeletal stable position during the 4-week trial period.
Also known as: occlusal splint
Tenderness of Masticatory Muscles and Periarticular Temporomandibular Joint Pain
Evaluated using the Numeric Rating Scale (NRS) 0-10, to measure pain intensity upon palpation of the masticatory muscles and the periarticular structures of the temporomandibular joint.
Time frame: Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
Pain-Free Mandibular Active Range of Motion
Measured as the maximum active mouth opening (maximum unassisted pain-free opening) in millimeters using a calibrated ruler.
Time frame: Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
Jaw Functional Limitation Scale - 20 (JFLS-20)
The Jaw Functional Limitation Scale-20 (JFLS-20) is a 20-item patient-reported questionnaire assessing jaw functional limitation during the previous month. Each item is rated from 0 (no limitation) to 10 (severe limitation). Domain scores are calculated as the mean of completed items for mastication (items 1-6), vertical jaw mobility (items 7-10), and verbal and non-verbal communication (items 11-20). The overall JFLS-20 score is the mean of the three domain scores. Scores range from 0 to 10; higher scores indicate greater jaw functional limitation and a worse outcome. A domain score is calculated when no more than 2 mastication items, 1 mobility item, or 2 communication items are missing.
Time frame: Baseline, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
Cervical active range of motion (AROM) limitation
Cervical AROM of flexion, extension, left/right rotation, and left/right lateral flexion is measured using a plastic universal goniometer in degrees from 0-80/40/45 etc. For reporting purposes, each movement is categorized as "normal", "limited", or "no movement", based on predefined cutoffs (e.g., rotation ≥80° = normal; 40-79° = limited; \<40° = no movement). The outcome is the proportion of participants with limited cervical AROM at each time point.
Time frame: Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
MRI T2-Weighted Soft Tissue Assessment
T2-weighted MRI scans were compared with T1-weighted images to identify joint effusion, disc displacement, perimuscular/intramuscular edema, and muscle hemorrhage.
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment endpoint).
Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks
The occurrence, type, severity, and frequency of adverse events and treatment-related discomfort associated with proprioceptive training, laser acupuncture, or stabilization splint therapy will be recorded. The number of participants experiencing at least one adverse event and the number of adverse events will be summarized by treatment group. Adverse events will be assessed at 2 weeks and 4 weeks, including the 4-week endpoint.
Time frame: 2 weeks and 4 weeks (endpoint)
Plan to share: No — Individual participant data will not be shared to protect patient privacy and comply with the institutional review board (IRB) regulations
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Temporomandibular Joint Disorders →
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