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Not yet recruitingNCT07531654Updated Apr 15, 2026

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

An interventional study of High Level Laser Therapy and Low Level Laser Therapy in Myofascial Pain Dysfunction Syndrome, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.
02

Conditions studied

  • Myofascial Pain Dysfunction Syndrome

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03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    High intensity Laser Therapy (HLLT)

    Device: High Level Laser Therapy

  • Active comparator
    Low Level Laser Therapy (LLLT)

    Device: Low Level Laser Therapy

Interventions

  • DeviceHigh 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.

  • DeviceLow 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.

06

What researchers measure

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.

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided — The data will be retained by the investigators for further internal analysis and research pruposes.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07531654
Lead sponsor
Cairo University
Responsible party
Ayman Mohamed Gouda (Assistant professor of Oral and Maxillofacial Surgery, Cairo University) — Principal investigator
First posted
Apr 15, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Nov 12, 2026 (estimated)
Completion
Dec 12, 2026 (estimated)
Last update
Apr 15, 2026

Study contacts

Ayman M Gouda, Phd
Contact
ayman.gouda@dentistry.cu.edu.eg
+0201006934468

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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