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NCT Number: NCT07531654

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

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.

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Key information

Conditions

Myofascial Pain Dysfunction Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of myofascial temporomandibular disorder following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • 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.
  • No previous laser therapy for last 3 months.
  • Pain localized to the masseter muscles.
  • 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

Treatment and study plan

High Level Laser Therapy

Device

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.

Low Level Laser Therapy

Device

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.

Primary outcomes

  1. Pain Assessment

    Time frame: 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 outcomes

  1. Maximal incisal opening

    Time frame: Maximal incisal opening is measured at each session, 1, 3 months and 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayman M Gouda, Phd

CONTACT

[email protected]

+0201006934468

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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