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

Not Applicable

Recruiting

• Conditions: Temporomandibular Joint Disorders

• Registration Number: NCT06419738
• Lead Sponsor: Hanoi Medical University

Brief 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.

Detailed 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 Timeline

• Study Start: 2023-03-14
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-01-04
• Study Completion: 2025-01-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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
Maximum mouth opening	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.
Numbers of masticatory muscle pain with palpation	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.
Numbers of supplemental muscle pain with palpation	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.

Secondary Outcome Measures

Name	Time	Method
Protrusive movements	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.
Right lateral movements	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.
OBC	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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
Left lateral movements	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.
GAD-7	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.
PHQ-9	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.
JFLS-8	Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up	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.

Trial Locations

Locations (1)

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