NCT07176039

Brief Summary

this randomized controlled trial aims to compare the effectiveness of High-Intensity Laser Therapy (HILT) and Extracorporeal Shockwave Therapy (ESWT) in managing patients with Myofascial Pain Syndrome (MPS). Thirty-two participants will be randomly assigned to receive either HILT or ESWT over a period of 4 weeks. Outcome measures include pain intensity (Visual Analog Scale), tenderness, functional disability, and cervical range of motion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

October 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

September 1, 2025

Last Update Submit

January 1, 2026

Conditions

Keywords

Myofascial Pain SyndromeHigh-Intensity Laser TherapyExtracorporeal Shockwave TherapyCervical PainPhysical TherapyPain Management

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) for Pain Intensity

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm line where 0 = "no pain" and 10 = "worst pain imaginable". A lower score indicates improvement. The primary outcome is the mean change from baseline to post-treatment.

    Baseline and 4 weeks after intervention (post-treatment)

Secondary Outcomes (3)

  • Pressure Pain Threshold (PPT) as measured by pressure algometer

    Baseline and 4 weeks post-treatment

  • Neck Disability Index (NDI)

    Baseline and 4 weeks post-treatment

  • Cervical Range of Motion (ROM)

    Baseline, 4 weeks

Study Arms (2)

High-Intensity Laser Therapy (HILT)

EXPERIMENTAL

Participants will receive High-Intensity Laser Therapy (HILT) applied to active myofascial trigger points in the neck and shoulder region, using an 808 nm GaAlAs laser, 8-10 W, 2000 Hz, 60 seconds per point, 5-6 points per session, twice weekly for 4 weeks (8 sessions total).

Radiation: High-Intensity Laser Therapy (HILT)

Extracorporeal Shockwave Therapy (ESWT)

ACTIVE COMPARATOR

Participants will receive Extracorporeal Shockwave Therapy (ESWT) using a radial shockwave device with energy flux density of 0.1-0.2 mJ/mm², 2000 shocks per session, administered twice weekly for 4 weeks (8 sessions).

Other: Extracorporeal Shockwave Therapy (ESWT)

Interventions

will be administered to active myofascial trigger points in the neck and shoulder region. The laser device used is an 808 nm gallium-aluminum-arsenide (GaAlAs) diode laser in continuous mode. Parameters: power output of 8-10 W, frequency of 2000 Hz, and application time of 60 seconds per trigger point, targeting 5-6 trigger points per session. Treatment will be delivered twice weekly for 4 consecutive weeks, totaling 8 sessions.

High-Intensity Laser Therapy (HILT)

ESWT will be applied to active myofascial trigger points using a radial shockwave device. Parameters: Energy flux density 0.1-0.2 mJ/mm², 2000 shocks per session, frequency of 2 sessions per week for 4 weeks (8 sessions).

Extracorporeal Shockwave Therapy (ESWT)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female participants aged 18-60 years. Diagnosis of Myofascial Pain Syndrome (MPS) in the neck/shoulder region. Presence of active myofascial trigger points in the upper trapezius. Willingness to provide informed consent.

You may not qualify if:

  • History of cervical spine surgery, trauma, or radiculopathy. Contraindications to laser or shockwave therapy. Presence of systemic diseases (e.g., rheumatoid arthritis, malignancy). Receiving other physical therapy interventions during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Benha University

Cairo, Egypt

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck PainAgnosia

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • reda K. Abdelrazik, associate professor

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Physical Therapy for musculoskeletal disorders and its surgery, Faculty of Physical Therapy, Benha University

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 16, 2025

Study Start

October 10, 2025

Primary Completion

November 20, 2025

Study Completion

December 1, 2025

Last Updated

January 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations