Efficacy of Combining Low Level Laser Therapy With Cognitive-behavioral Therapy on Myalgia in Temporomandibular Joint Disorders

Last updated: May 22, 2024
Sponsor: Hanoi Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Treatment

Cognitive behavioral treatment (CBT)

Low level laser therapy combined with CBT (LLLT+CBT)

Occlusal Splint combined with CBT (OS+CBT)

Clinical Study ID

NCT06419738
NCS01050122107
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with Temporomandibular joint Disorders (according to DC/TMD) withacute 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 opinionand complying with the examination process.

Exclusion

Exclusion Criteria:

  • Patients with chronic TMDs pain, swelling and pain in the mouth that prevent wearinga occlusal splint.

  • Patients with history of severe neurological disorders, autoimmune joint and musclediseases, advanced malignant cancer, history of mental illness, history ofalcoholism, drug and painkiller abuse, undergoing surgery and/or radiotherapy on theneck and face, other treatments on the neck and temporomandibular joint within 3months, use of drugs that may affect the neuromuscular system.

  • Pregnant patients

Study Design

Total Participants: 66
Treatment Group(s): 3
Primary Treatment: Cognitive behavioral treatment (CBT)
Phase:
Study Start date:
March 14, 2023
Estimated Completion Date:
January 04, 2025

Study Description

The purpose of this study is to evaluate the efficacy of combining low level laser therapy and cognitive behavioral treatment 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.

Connect with a study center

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

    Ha Noi, 11300
    Vietnam

    Active - Recruiting

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