Comparative Effectiveness of Standard and Modified Laser Therapy in Myofascial Pain Management.

Comparative Effectiveness of Standard and Modified Laser Therapy in Myofascial Pain Management: A Randomized Clinical Trial

The goal of this clinical trial is to evaluate and compare the effectiveness of modified laser therapy versus conventional laser therapy in managing pain and mandibular function in patients with chronic myofascial pain syndrome involving the masseter muscles. The main questions it aims to answer are:

1. Does high-intensity laser therapy (HILT) provide a greater reduction in pain intensity on a numerical rating scale (NRS) compared to low-level laser therapy (LLLT)?
2. Does high-intensity laser therapy (HILT) provide greater improvement in functional outcomes, specifically maximal incisal opening, compared to low-level laser therapy (LLLT)?

Comparison Group:

Researchers will compare the experimental group receiving High-Intensity Laser Therapy (HLLT) to a comparator group receiving Low-Level Laser Therapy (LLLT) to see if the modified high-intensity approach provides superior pain relief and improved mandibular movement.

Participants will:

1. Be randomly assigned to either the HILT or LLLT treatment group.
2. Undergo 12 laser irradiation sessions delivered over one month.
3. Have laser energy applied directly to the trigger points of the masseter muscles during 5-minute sessions.
4. Attend follow-up assessments at each session, and at intervals of 1, 3, and 6 months.
5. Provide pain ratings using a numerical scale and have their maximal mouth opening measured by a caliper.

Study Overview

• Status: Not yet recruiting
• Conditions: Myofascial Pain Dysfunction Syndrome
• Intervention / Treatment: Device: High Level Laser Therapy; Device: Low Level Laser Therapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman M Gouda, Phd; Phone Number: +0201006934468; Email: ayman.gouda@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of myofascial temporomandibular disorder following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
2. Participants eligible for inclusion in this study must not have received any previous laser therapy for the management of myofascial pain dysfunction syndrome or temporomandibular disorders like pharmacological therapy, physical therapy, manual techniques, and trigger point injections.
3. No previous laser therapy for last 3 months.
4. Pain localized to the masseter muscles.
5. Pain lasting at least 3 months with a self-reported pain level of 6 or higher on a numerical rating scale (NRS).

Exclusion Criteria:

1- Patients with TMJ pain, or those who had any previous treatment for TMD 2- Patients with any history of cervical or degenerative conditions, any surgery or trauma to the neck during last year 3- Previous treatment of MPDS during last year 4- Confirmed diagnosis of fibromyalgia or rheumatoid arthritis 5- Patients with dark skin tone or chubby face

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity Laser Therapy (HLLT)	Device: High Level Laser Therapy; Laser energy density of 3 KJ will be applied to the masseter muscles using an epic-x940 nm diode laser, with 12 irradiation sessions delivered over one month. The mode of laser was a continuous wave irradiation for 5 minutes, distance to Tissue~1 cm, and the area of the laser delivery tip was 5 cm2. The trigger point was identified within the affected muscle.
Active Comparator: Low Level Laser Therapy (LLLT)	Device: Low Level Laser Therapy; Laser energy density of 1.5 KJ will be applied to the masseter muscles using an epic-x940 nm diode laser (BioLase, USA), with 12 irradiation sessions delivered over one month. The mode of laser was a continuous wave irradiation for 5 minutes, distance to Tissue~1 cm, and the area of the laser delivery tip was 5 cm2. The trigger point was identified within the affected muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Assessment	Pain will be assessed using a numerical rating scale (NRS) at rest and during mouth opening at the following follow up time points: at each session, 1, 3 months and 6 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximal incisal opening	Maximal incisal opening is measured at each session, 1, 3 months and 6 months.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): December 12, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 2025/0081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be retained by the investigators for further internal analysis and research pruposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No