Clinical trial NCT06419738: Efficacy of Combining Low Level Laser Therapy With Cognitive-behavioral Therapy on Myalgia in Temporomandibular Joint Disorders
Official title: Clinical, Psychosocial, Behavioral Characteristics and Treatment Effectiveness of Low Level Laser Therapy on Patients With Temporomandibular Joint Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, temporomandibular disorders treatment
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 66
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: Numbers of masticatory muscle pain with palpation
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: Maximum mouth opening
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: Numbers of supplemental muscle pain with palpation
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
Secondary outcomes:
measure: Right lateral movements
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: Left lateral movements
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: Protrusive movements
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: JFLS-8
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: GAD-7
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: PHQ-9
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
measure: OBC
timeFrame: Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up
Other outcomes:
Locations:
city: Ha Noi
country: Vietnam
facility: High-tech center for Ondonto-stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University
Study officials:
References:
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