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

Neveen Abd El Maksoad Kohaf

Status: Begins enrollment this month

Conditions: Myofascial Pain Syndrome (MPS)

Treatments: Device: High-Intensity Laser Therapy; Device: Sham Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07352787

HILT-TMPS-2026-4P-DEVVAL

Details and patient eligibility

About

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.

Full description

Myofascial pain syndrome of the trapezius muscle is a common cause of chronic neck and shoulder pain associated with functional limitation and psychological distress. Although High-Intensity Laser Therapy is increasingly used in clinical practice, high-quality evidence regarding its long-term effects and optimal treatment parameters is limited.

This double-blind, randomized, placebo-controlled trial will enroll 104 adults with clinically diagnosed trapezius myofascial pain syndrome. Participants will be randomly assigned to receive either optimized High-Intensity Laser Therapy or sham laser treatment. Outcomes will be assessed at baseline, immediately after the intervention, and at 16-week follow-up. This study aims to provide evidence for a standardized, patient-centered HILT protocol suitable for routine clinical practice.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 to 65 years
• Clinically diagnosed trapezius myofascial pain syndrome
• Duration of symptoms ≥ 4 weeks
• Pain intensity ≥ 4 on NPRS
• Able to provide informed consent

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups, including a placebo group

High-Intensity Laser Therapy (HILT)

Experimental group

Description:

Participants in this arm will receive active High-Intensity Laser Therapy applied to the trapezius muscle region for the treatment of trapezius myofascial pain syndrome.

Treatment:

Device: High-Intensity Laser Therapy

Sham Laser Therapy

Placebo Comparator group

Description:

Participants in this arm will receive sham laser therapy applied to the trapezius muscle region. The sham procedure will mimic the appearance and application of active laser therapy without delivering therapeutic laser energy.

Treatment:

Device: Sham Laser Therapy