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

NCT06419738 | Completed DMC

• 1 other identifier: NCS01050122107
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disorders; Facial Pain

Keywords

temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, temporomandibular disorders treatment; temporomandibular joint disorders; temporomandibular disorders; low-level laser therapy; self - management program; occlusal splint; Treatment of temporomandibular disorders

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Right lateral movements

  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

  Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

• Protrusive movements

  Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

• JFLS-8

  Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

• GAD-7

  Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

Study Arms (3)

Self-Management Program

ACTIVE COMPARATOR

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

Low level laser therapy combined with Self-Management Program

EXPERIMENTAL

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; Radiation: Low level laser therapy combined with Self-Management Program

Occlusal Splint combined with Self-Management Program

ACTIVE COMPARATOR

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; Device: Occlusal Splint combined with Self-Management Program

Interventions

Self-Management Program BEHAVIORAL

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; Occlusal Splint combined with Self-Management Program; Self-Management Program

Low level laser therapy combined with Self-Management Program RADIATION

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.

Low level laser therapy combined with Self-Management Program

Occlusal Splint combined with Self-Management Program DEVICE

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.

Occlusal Splint combined with Self-Management Program

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

High-tech center for Ondonto-stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University

Hà Nội, 11300, Vietnam

Location

Related Publications (8)

• 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.

  PMID: 23318917 RESULT

• 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.

  PMID: 34104237 RESULT

• 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.

  PMID: 29861802 RESULT

• 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.

  PMID: 26587294 RESULT

• 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.

  PMID: 36274894 RESULT

• 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.

  PMID: 29682258 RESULT

• 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.

  PMID: 37744015 RESULT

• 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.

  PMID: 24504660 RESULT

Related Links

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

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 66 patients were divided into 3 groups.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 by using Excel software to create a random number table, patients will draw even numbers into group 2, odd numbers into group 1. * 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.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: March 14, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

VN (1)