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

January 13, 2026 updated by: Neveen Abd El Maksoad Kohaf

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Nasiriyah
      • Nasiriyah, Nasiriyah, Iraq, 64001
        • Al-Hussein Teaching Hospital
        • Contact:
          • Mohammed Ali Hassan Jassim, MSc in physiotherapy
          • Phone Number: 009647818162160
          • Email: Mohmdg85@gmail.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Intensity Laser Therapy (HILT)
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.
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 promote analgesia, improve microcirculation, reduce muscle tension, and facilitate tissue healing.
Placebo Comparator: Sham Laser Therapy
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Disability
Time Frame: 16-week follow-up
Neck Disability Index (NDI)
16-week follow-up
Cervical Range of Motion
Time Frame: 16-week follow-up
Measured using CROM device
16-week follow-up
Depression
Time Frame: 16-week follow-up
Beck Depression Inventory-II (BDI-II)
16-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neveen Abd El Maksoad Kohaf

Collaborators

Universiti Kebangsaan Malaysia Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

April 10, 2027

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HILT-TMPS-2026-4P-DEVVAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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