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NCT Number: NCT07352787

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

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.

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Key information

Conditions

Myofascial Pain Syndrome (MPS) Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain Intensity

    Time frame: 16-week follow-up

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

Secondary outcomes

  1. Functional Disability

    Time frame: 16-week follow-up

    Neck Disability Index (NDI)

  2. Cervical Range of Motion

    Time frame: 16-week follow-up

    Measured using CROM device

  3. Depression

    Time frame: 16-week follow-up

    Beck Depression Inventory-II (BDI-II)

Sponsors and collaborators

Lead sponsor

Neveen Abd El Maksoad Kohaf

Other

Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

Registry information

Official study title

High-Intensity Laser Therapy for Trapezius Myofascial Pain Syndrome: Effects on Pain, ROM, Function, and Depression A Four-Phase Development, Validation, and Evaluation Study

Acronym: HILT-TRAP Stud

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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