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

Temporomandibular Joint Disorders Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Joint Diseases
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome
Clinical Trial Details
NCT number NCT06419738
Study type Interventional
Source Hanoi Medical University
Contact Hoa Nguyen Ngoc, Resident doctor
Phone +84 0906235460
Email nguyenngochoa@hmu.edu.vn
Status Recruiting
Phase N/A
Start date March 14, 2023
Completion date January 4, 2025
View Details
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