Comparison of Low-Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain in Temporomandibular Disorders

NCT ID: NCT06790667

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-07-15

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.

Conditions

Myofascial Temporomandibular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Participants in this arm will receive LLLT for the treatment of myofascial pain associated with TMD.

Group Type: OTHER

Low Level Laser Therapy

Intervention Type: DEVICE

Participants in this arm will receive Low-Level Laser Therapy (LLLT) using a Gallium Aluminum Arsenide (GaAlAs) semiconductor diode laser. The treatment involves a wavelength range of 650-808 nm with a power output of 775 mW. The therapy is administered by exposing tender points around the temporomandibular joint (TMJ) to the laser for 2 minutes per session. Each participant will receive treatment on alternate days (three sessions per week) over the course of three weeks. The goal is to assess the effectiveness of LLLT in reducing pain and improving mouth opening in patients with myofascial pain associated with Temporomandibular Disorders (TMD).

Group B

Participants in this arm will receive TENS for the treatment of myofascial pain associated with TMD.

Group Type: EXPERIMENTAL

Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)

Intervention Type: DEVICE

Participants in this arm will undergo Transcutaneous Electrical Nerve Stimulation (TENS), utilizing a four-electrode unit. The device will be set to deliver electrical impulses at a frequency of 150 Hz with a pulse width of 200 µs. Electrodes will be placed over the cutaneous region between the TMJ and coronoid process to stimulate the trigeminal and facial nerves. Each treatment session will last 15 minutes and occur on alternate days, three times a week for three weeks. This therapy aims to provide pain relief and improve jaw function for patients suffering from myofascial pain associated with TMD.

Interventions

Low Level Laser Therapy

Participants in this arm will receive Low-Level Laser Therapy (LLLT) using a Gallium Aluminum Arsenide (GaAlAs) semiconductor diode laser. The treatment involves a wavelength range of 650-808 nm with a power output of 775 mW. The therapy is administered by exposing tender points around the temporomandibular joint (TMJ) to the laser for 2 minutes per session. Each participant will receive treatment on alternate days (three sessions per week) over the course of three weeks. The goal is to assess the effectiveness of LLLT in reducing pain and improving mouth opening in patients with myofascial pain associated with Temporomandibular Disorders (TMD).

Intervention Type: DEVICE

Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)

Participants in this arm will undergo Transcutaneous Electrical Nerve Stimulation (TENS), utilizing a four-electrode unit. The device will be set to deliver electrical impulses at a frequency of 150 Hz with a pulse width of 200 µs. Electrodes will be placed over the cutaneous region between the TMJ and coronoid process to stimulate the trigeminal and facial nerves. Each treatment session will last 15 minutes and occur on alternate days, three times a week for three weeks. This therapy aims to provide pain relief and improve jaw function for patients suffering from myofascial pain associated with TMD.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

ARHUM BUTT

Postgraduate Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arhum Butt, Bachelor of Dental Surgery

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences Lahore

Central Contacts

Arhum Butt

Role: CONTACT

arhum555@hotmail.com

+92-333-4065258

Other Identifiers

UNIVERSITY OF HEALTH SCIENCES

Identifier Type: -

Identifier Source: org_study_id