Comparative Effectiveness of Standard and Modified Laser... | NCT07531654

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

NCT07531654

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Apr 15, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Myofascial Pain Dysfunction Syndrome

Interventions

High Level Laser Therapy
Low Level Laser Therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2026Estimated

Primary Completion Date

Nov 12, 2026Estimated

Completion Date

Dec 12, 2026Estimated

First Submitted Date

Apr 9, 2026

First Submission Date that Met QC Criteria

Apr 9, 2026

First Posted Date

Apr 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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)?
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:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High intensity Laser Therapy (HLLT)	Experimental		Device: High Level Laser Therapy
Low Level Laser Therapy (LLLT)	Active Comparator		Device: Low Level Laser Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ayman M Gouda, Phd	Contact	+0201006934468		ayman.gouda@dentistry.cu.edu.eg

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The data will be retained by the investigators for further internal analysis and research pruposes.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy