Efficacy of Combining Low-Level Laser Therapy With a Self-Management Program on Myalgia in Temporomandibular Disorders
NCT ID: NCT06419738
Last Updated: 2026-01-27
Study Results
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Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2023-03-14
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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 each time, 10 times in total, combined with counseling, behavior modification, and exercise.
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* All patients aged 16 years or older, capable of comprehending the doctor's opinion and complying with the examination process.
Exclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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Hanoi Medical University
OTHER
Responsible Party
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Nguyen Ngoc Hoa
Lecturer
Locations
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High-tech center for Ondonto-stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University
Hà Nội, , Vietnam
Countries
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References
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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.
Related Links
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Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled Trial
Other Identifiers
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NCS01050122107
Identifier Type: -
Identifier Source: org_study_id
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