NCT07352787

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

January 4, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2027

Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

January 4, 2026

Last Update Submit

January 13, 2026

Conditions

Myofascial Pain Syndrome (MPS)

Keywords

High-Intensity Laser TherapyTrapezius Myofascial Pain SyndromeRandomized Controlled TrialNeck PainPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    16-week follow-up

Secondary Outcomes (3)

  • Functional Disability

    16-week follow-up

  • Cervical Range of Motion

    16-week follow-up

  • Depression

    16-week follow-up

Study Arms (2)

High-Intensity Laser Therapy (HILT)

EXPERIMENTAL

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

Sham Laser Therapy

PLACEBO COMPARATOR

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

Interventions

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.

Sham Laser Therapy
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.

High-Intensity Laser Therapy (HILT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Hussein Teaching Hospital

Nasiriyah, Nasiriyah, 64001, Iraq

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt.

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 20, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

April 10, 2027

Last Updated

January 20, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)