Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419738
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-14
Brief Title:
Efficacy of Combining Low Level Laser Therapy With Cognitive-behavioral Therapy on Myalgia in Temporomandibular Joint Disorders
Sponsor:
Hanoi Medical University
Organization:
Hanoi Medical University
Study Overview
Official Title:
Clinical Psychosocial Behavioral Characteristics and Treatment Effectiveness of Low Level Laser Therapy on Patients With Temporomandibular Joint Disorders
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 DCTMD 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 160 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 005 is considered statistically significant
66 patients suffering from acute and subacute myalgia diagnosed using Diagnostic Criteria for Temporomandibular Disorders DCTMD 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 160 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 005 is considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None