NCT07531654

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myofascial Pain Dysfunction Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-11-12
• Completion: 2026-12-12
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Egypt