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High-Intensity Laser Therapy for Trapezius Myofascial Pain (HILT-TRAP Study)

ConditionMyofascial Pain Syndrome (MPS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeveen Abd El Maksoad Kohaf

About this trial

This study aims to evaluate the effectiveness of optimized High-Intensity Laser Therapy (HILT) compared with sham treatment in patients with trapezius myofascial pain syndrome. Outcomes include pain intensity, cervical range of motion, functional disability, and depressive symptoms measured at baseline, post-intervention, and 16-week follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 65 years

Clinically diagnosed trapezius myofascial pain syndrome

Duration of symptoms ≥ 4 weeks

Pain intensity ≥ 4 on NPRS

Disqualifiers

Red-flag medical conditions (e.g., malignancy, spinal cord compression)

Neurological disorders affecting the neck or shoulder

Cognitive impairment or inability to communicate

Previous laser therapy to the neck/shoulder region within the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Intensity Laser Therapy

    Device

    High-Intensity Laser Therapy will be administered using a class IV therapeutic laser device applied over identified trapezius myofascial trigger points and surrounding muscle tissue. Treatment parameters (wavelength, power output, energy density, and duration) will follow standardized clinical protocols and safety guidelines. Sessions will be delivered by a licensed physical therapist, with participants receiving multiple treatment sessions over the intervention period. The therapy aims to promote analgesia, improve microcirculation, reduce muscle tension, and facilitate tissue healing.

  • Sham Laser Therapy

    Device

    Sham laser therapy will be administered using an identical laser device and treatment procedure; however, no therapeutic laser energy will be emitted. The duration, frequency, and therapist interaction will be identical to the active treatment.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: High-Intensity Laser Therapy (HILT)Experimental treatment 1 intervention
Group B: Sham Laser TherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity

Pain intensity will be evaluated using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.

Time frame
16-week follow-up

Secondary outcomes

1

Functional Disability

Neck Disability Index (NDI)

Time frame
16-week follow-up
2

Cervical Range of Motion

Measured using CROM device

Time frame
16-week follow-up
3

Depression

Beck Depression Inventory-II (BDI-II)

Time frame
16-week follow-up

Other outcomes

Sponsors and contacts

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

Neveen Abd El Maksoad Kohaf

Lead sponsor

Al-Azhar University

Sponsor institution

Universiti Kebangsaan Malaysia Medical Centre

Collaborator

Source ClinicalTrials.gov

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