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

N/ANot Yet RecruitingNCT07352787

Neveen Abd El Maksoad Kohaf104 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Myofascial Pain Syndrome (MPS)

Interventions

High-Intensity Laser TherapyDEVICE

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 TherapyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Al-Hussein Teaching Hospital

Nasiriyah, Nasiriyah, Iraq

Outcomes

Primary Outcomes

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

Functional Disability

Neck Disability Index (NDI)

Time frame: 16-week follow-up

Cervical Range of Motion

Measured using CROM device

Time frame: 16-week follow-up

Depression

Beck Depression Inventory-II (BDI-II)

Time frame: 16-week follow-up

Data from ClinicalTrials.gov

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