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

NCT06790667 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: UNIVERSITY OF HEALTH SCIENCES
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Pain Intensity (VAS Score)

  Change in pain intensity as measured by the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain) Unit of Measure: Centimeters (cm) Time Points: Pre-treatment, 1st week, 3rd week, and 4th week.

  6 months

• Mouth Opening (Active Interincisal Distance)

  Change in active interincisal distance, measured using a ruler from the upper to lower incisal edges during maximum unassisted mouth opening. Unit of Measure: Millimeters (mm). Time Points: Pre-treatment, 1st week, 3rd week, and 4th week

  6 months

Study Arms (2)

Group A

OTHER

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

Device: Low Level Laser Therapy

Group B

EXPERIMENTAL

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

Device: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)

Interventions

Low Level Laser Therapy 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 A

Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) 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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Arhum Butt, Bachelor of Dental Surgery

  University of Health Sciences Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arhum Butt

CONTACT

+92-333-4065258; arhum555@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident

Model Details: 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).

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: July 15, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share