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Not yet recruiting NCT07352787

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

No phase Interventional Myofascial Pain Syndrome (MPS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Intensity Laser Therapy, Sham Laser Therapy.
Who it may be relevant to
Registry conditions: Myofascial Pain Syndrome (MPS). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Detailed 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.

Interventions

  • Device High-Intensity Laser Therapy
    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 promo
  • Device Sham Laser Therapy
    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 outcome measures

  • Pain Intensity [Time frame: 16-week follow-up]
Secondary outcome measures (3)
  • Functional Disability [Time frame: 16-week follow-up]
  • Cervical Range of Motion [Time frame: 16-week follow-up]
  • Depression [Time frame: 16-week follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Iraq · 1 center
  • Al-Hussein Teaching Hospital — Nasiriyah

Identifiers

NCT: NCT07352787 · HILT-TMPS-2026-4P-DEVVAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗