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

ConditionMyofascial Pain Dysfunction Syndrome

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: High intensity Laser Therapy (HLLT)Experimental treatment 1 intervention

Group B: Low Level Laser Therapy (LLLT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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

Maximal incisal opening

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: