Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-01 @ 8:03 AM
Study NCT ID:
NCT06790667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Low-Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain in Temporomandibular Disorders
Sponsor:
University of Health Sciences Lahore
Organization:
Study Overview
Official Title:
Comparative Effectiveness of Low Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation on Pain and Mouth Opening in Temporomandibular Disorders Based Upon Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
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:
Myofascial pain is the most common form of temporomandibular disorder (TMD) encountered in maxillofacial practice. Treatment options range from conservative management to open surgical procedures, with physical therapies identified as the safest and most effective. Among these, transcutaneous electrical nerve stimulation (TENS) is a widely used technique, while low-level laser therapy (LLLT) is a recent therapeutic advancement. This study is designed to compare the efficacy of these two therapies, aiming to identify the more effective option.
Detailed Description:
A randomized clinical trial will be conducted at the Oral and Maxillofacial Surgery department, Punjab Dental Hospital, Lahore. Sample size of 40 patients will be selected through convenience sampling and divided into two equal groups, based on computergenerated random numbers. A written consent will be obtained from all the participants. Group A will receive LLLT, while Group B will receive TENS. The primary variables like pain score and mouth opening will be recorded preoperatively and during followup sessions. The proforma used for data collection will be designed, tailored to the needs of this study based on standard Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Both groups will receive their assigned therapies on alternate days for three weeks, with evaluations at 1st, 3rd, and 4th weeks post-treatment. All collected data will be entered into SPSS version 25 for statistical analysis. Independent sample t-test will be used to compare the mean pain score and mouth opening between the two groups. Repeated measures ANOVA will be applied to compare the primary variables in both groups on all follow-ups. P-value ≤0.05 will be considered as significant.
This study aims to offer tailored insights and practical recommendations, potentially improving patient care by providing safer and non-invasive alternatives to more invasive procedures thus enhancing overall treatment strategies. It is assumed that expected results shall be in favor of the LLLT group. Possible limitations may include failure of patients to come for multiple sessions.
This study aims to offer tailored insights and practical recommendations, potentially improving patient care by providing safer and non-invasive alternatives to more invasive procedures thus enhancing overall treatment strategies. It is assumed that expected results shall be in favor of the LLLT group. Possible limitations may include failure of patients to come for multiple sessions.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: