Clinical trial NCT06790667: Comparison of Low-Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain in Temporomandibular Disorders
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Myofascial Temporomandibular Disorders
Keywords: Randomized clinical trial
temporomandibular disorder
myofascial pain
Low-level laser therapy
Transcutaneous Electrical Nerve Stimulation
Jaw Pain Treatment
Mouth opening improvement
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants shall be randomly assigned to receive either:

Low-Level Laser Therapy (LLLT), or Transcutaneous Electrical Nerve Stimulation (TENS).

Both groups will be monitored for outcomes like pain reduction and mouth opening improvement over the same timeline, with no participant switching between treatments.

This approach ensures unbiased comparison of the effectiveness of LLLT and TENS in treating myofascial pain in Temporomandibular Disorders (TMD).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed cases of myofascial pain in TMD patients, which fall under diagnostic criteria (DC/TMD).
2. Myofascial pain that persists for more than 3 months.
3. Involvement of trigger points in the masseter and temporalis muscles.
4. Impaired or limited mouth opening (less than 35mm).

Exclusion Criteria:

1. Congenital abnormality or neoplastic condition around TMJ.
2. Recent history of trauma affecting head and neck region.
3. Patients with known dermatological disorders (eczema, psoriasis).
4. Patients with pacemakers and cardiovascular diseases.
5. Epileptic patients.
6. Patients allergic to adhesive tapes or electrodes of TENS

Primary outcomes:
measure: Pain Intensity (VAS Score)
timeFrame: 6 months
measure: Mouth Opening (Active Interincisal Distance)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Health Sciences Lahore
name: Arhum Butt, Bachelor of Dental Surgery
role: PRINCIPAL_INVESTIGATOR
References: