Efficacy of Combining Low-Level Laser Therapy With a Self-Management Program on Myalgia in Temporomandibular Disorders (LASER-SM)

Clinical, Psychosocial, Behavioral Characteristics and Treatment Effectiveness of Low Level Laser Therapy on Patients With Temporomandibular Joint Disorders

The purpose of this study is to evaluate the efficacy of combining low-level laser therapy and the self-management program for patients with temporomandibular joint disorders using a randomized controlled design.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders; Facial Pain
• Intervention / Treatment: Behavioral: Self-Management Program; Radiation: Low level laser therapy combined with Self-Management Program; Device: Occlusal Splint combined with Self-Management Program

Detailed Description

The purpose of this study is to evaluate the efficacy of combining low level laser therapy and self-management program for patients with temporomandibular joint disorders using a randomized controlled design.

66 patients suffering from acute and subacute myalgia diagnosed using Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) at High-tech Center for Odonto-Stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University, Viet Nam. Patients without treatment (because of economic or geographical conditions) were persuaded to join the control group. Group 3 includes 22 patients who will be counseled on changing habits, adjusting behavior, exercising and will be taken in order of examination. 44 patients will be randomized into the remaining 2 groups:

• Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise.
• Group 2: recieve low level laser treatment 3 times aweek, 20 seconds/ session, 10 sessions in total, combined with counseling, behavior modification, and exercise.

Assessment takes place at baseline, after treatment approximately 2 weeks, 4 weeks, 12 weeks, 24 weeks later and 48 weeks follow up. The effects of the interventions are evaluated in terms of reduction in pain intensity (Visual Analogue Scale-VAS), number of masticatory muscle pain point with palpation, number of supplemental muscle pain with palpation, maximum mouth opening, right lateral movements, left lateral movements, protrusive movements, Jaw functional limitation scale (JFLS-8), psychological variables such as PHQ-9, PHQ-4, GAD-7.

Data were entered and analyzed by SPSS 16.0 software. Use Mann-Whitney U test, Kruskal-Wallis test, and Wilcoxon test applied to non-normally distributed variables to compare VAS between groups at different follow-up times. Use paired t-test and independent t-test to compare the maximum opening, lateral movements, protrusive movements, JFLS-8, PHQ-9, PHQ-4, GAD-7 between groups before and after treatment. p value < 0.05 is considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hà Nội, Vietnam, 11300
    • High-tech center for Ondonto-stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with Temporomandibular joint Disorders (according to DC/TMD) with acute or subacute temporal muscle and/or masseter muscle pain (less than 3 months).
• All patients aged 16 years or older, capable of comprehending the doctor's opinion and complying with the examination process.

Exclusion Criteria:

• Patients with chronic TMDs pain, swelling and pain in the mouth that prevent wearing a occlusal splint.
• Patients with history of severe neurological disorders, autoimmune joint and muscle diseases, advanced malignant cancer, history of mental illness, history of alcoholism, drug and painkiller abuse, undergoing surgery and/or radiotherapy on the neck and face, other treatments on the neck and temporomandibular joint within 3 months, use of drugs that may affect the neuromuscular system.
• Pregnant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-Management Program; Self-Management Program includes education about the disorder, proprioceptive awareness, and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.	Behavioral: Self-Management Program; Self-Management Program includes education about the disorder, proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.
Experimental: Low level laser therapy combined with Self-Management Program; LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shone on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1.	Behavioral: Self-Management Program; Self-Management Program includes education about the disorder, proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.; Radiation: Low level laser therapy combined with Self-Management Program; LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shined on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1.
Active Comparator: Occlusal Splint combined with Self-Management Program; Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks. In addition, patients are still instructed Self-Management Program as group 1.	Behavioral: Self-Management Program; Self-Management Program includes education about the disorder, proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.; Device: Occlusal Splint combined with Self-Management Program; Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks.In addition, patients are still instructed Self-Management Program as group 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	The VAS (Visual Analog Scale) pain scale consists of a 10 cm long straight line (without marks), with "no pain" written at the left end and "unbearable pain" written at the right end. Patients were instructed to mark a vertical line above the horizontal line indicating the intensity of their pain. The distance from the zero point to the marker is then measured in millimeters by a caliper. Add the total score of the answers to evaluate the severity according to the following scale: ≤3.4: mild; 3.5-7.4: average; ≥ 7.5: severe	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of masticatory muscle pain with palpation	Numbers of muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Maximum mouth opening	Maximum mouth opening (MMO) was defined asthe maximal interincisal distance on unassisted active mouth opening when the patient opens his mouth maximally without feeling pain. Use a ruler with mm value.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of supplemental muscle pain with palpation	Numbers of supplemental muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right lateral movements	Ask the patient to open slightly, and to move his or her jaw as far as he/she can to the right, even if it is painful. Measure from the maxillary reference midline to the mandibular reference midline.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Left lateral movements	Ask the patient to open slightly, and to move his or her jaw as far as he/she can to the left, even if it is painful. Measure from the maxillary reference midline to the mandibular reference midline.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Protrusive movements	Ask the patient to open slightly, and to move his or her jaw as far as he/she can forward, even if it is painful. Measure the distance from the buccal surface of the mandibular tooth to the buccal surface of the maxillary tooth.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
JFLS-8	JFLS-8 (Jaw Functional Limitation Scale - 8) according to DC/TMD axis II to evaluate the level of mandibular function limitation in the past 30 days. The patient will be instructed to answer the questionnaire: in case the patient avoids the activity completely because it is too difficult to do, the patient will circle '10'. If the patient avoids an activity not for pain or difficulty, he/ she will leave this section blank. Activities include: chewing hard foods, chewing chicken, eating soft foods without chewing, opening mouth wide enough to drink from a cup, swallowing, yawning, speaking, laughing.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
GAD-7	General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 ('not at all') to 3 ('more than half of the days') rating scale (range 7-21). Higher scores indicate higher levels of anxiety.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
PHQ-9	Patient Health Questionnaire-9 is a depression assessment form. Patients answer questions consisting of 9 items. Responses will be scored as follows: none: 0 points; several days: 1 point; more than half of the days of the week: 2 points; almost every day: 3 points. Add the total score of the answers to evaluate the severity according to the following scale: 0-4 points: normal; 5-9 points: mild; 10-14 points: average; 15-19 points: quite severe; 20-27 points: severe.	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
OBC	Oral behaviors checklist (OBC) is to determine the presence of parafunctional behaviors. The score is calculated by summing the validation scores of the corresponding items. Response options are scored 0-4 for each item. Based on a comparison of people with chronic TMDs to people without TMDs, scores of 0-16 are normal, while scores of 17-24 occur twice as often in people with TMDs, and scores of 25-62 occur 17 times more often. Acting as a risk factor for TMDs, a score between 25-62 contributes to the onset of TMDs	Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Publications and helpful links

General Publications

• Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.
• Ahmad SA, Hasan S, Saeed S, Khan A, Khan M. Low-level laser therapy in temporomandibular joint disorders: a systematic review. J Med Life. 2021 Mar-Apr;14(2):148-164. doi: 10.25122/jml-2020-0169.
• Xu GZ, Jia J, Jin L, Li JH, Wang ZY, Cao DY. Low-Level Laser Therapy for Temporomandibular Disorders: A Systematic Review with Meta-Analysis. Pain Res Manag. 2018 May 10;2018:4230583. doi: 10.1155/2018/4230583. eCollection 2018.
• Ayyildiz S, Emir F, Sahin C. Evaluation of Low-Level Laser Therapy in TMD Patients. Case Rep Dent. 2015;2015:424213. doi: 10.1155/2015/424213. Epub 2015 Oct 26.
• Desai AP, Roy SK, Semi RS, Balasundaram T. Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled Trial. J Maxillofac Oral Surg. 2022 Sep;21(3):948-956. doi: 10.1007/s12663-021-01591-4. Epub 2021 May 25.
• Basili M, Barlattani A Jr, Venditti A, Bollero P. Low-level laser therapy in the treatment of muscle-skelet pain in patients affected by temporo-mandibular disorders. Oral Implantol (Rome). 2017 Jan 21;10(4):406-411. doi: 10.11138/orl/2017.10.4.406. eCollection 2017 Oct-Dec.
• Farshidfar N, Farzinnia G, Samiraninezhad N, Assar S, Firoozi P, Rezazadeh F, Hakimiha N. The Effect of Photobiomodulation on Temporomandibular Pain and Functions in Patients With Temporomandibular Disorders: An Updated Systematic Review of the Current Randomized Controlled Trials. J Lasers Med Sci. 2023 Aug 5;14:e24. doi: 10.34172/jlms.2023.24. eCollection 2023.
• Demirkol N, Sari F, Bulbul M, Demirkol M, Simsek I, Usumez A. Effectiveness of occlusal splints and low-level laser therapy on myofascial pain. Lasers Med Sci. 2015 Apr;30(3):1007-12. doi: 10.1007/s10103-014-1522-7. Epub 2014 Feb 7.

Helpful Links

• Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled Trial

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: low-level laser therapy; temporomandibular joint disorders; temporomandibular disorders; occlusal splint; temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, temporomandibular disorders treatment; self - management program; Treatment of temporomandibular disorders
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Temporomandibular Joint Disorders; Facial Pain; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Self-Management
• Other Study ID Numbers: NCS01050122107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Investigators have no plans to publish data related to research participants because all patients included in the doctoral training project of Hanoi Medical University have signed a commitment not to disclose information about the patients in the Ethics Committee's Consent to Participate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No