Comparison Between High-Intensity Laser Therapy and Extracorporeal Shockwave Therapy in the Treatment of Myofascial Pain Syndrome

NCT07176039 | Completed

• 1 other identifier: PT.BU.EC.23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized single-blind controlled trial compares the effectiveness of High-Intensity Laser Therapy (HILT) versus Extracorporeal Shockwave Therapy (ESWT), both combined with standardized traditional physiotherapy, in patients with upper trapezius myofascial pain syndrome. Forty participants will be randomly assigned to receive either HILT (12 sessions over 4 weeks) or ESWT (4 sessions over 4 weeks). Primary outcome is pain intensity (NPRS); secondary outcomes include pressure pain threshold, neck disability index, and cervical range of motion.

Conditions

Myofascial Pain Syndrome - Neck

Keywords

Myofascial Pain Syndrome; High-Intensity Laser Therapy; Extracorporeal Shockwave Therapy; Cervical Pain; Physical Therapy; Pain Management

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale for Pain Intensity

  Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 = "no pain" and 10 = "worst imaginable pain". Assessments will be conducted at rest and during active cervical movement. The primary metric is the mean change in NPRS score from baseline to post-treatment (week 4). Lower scores indicate improvement. \[Time Frame: Baseline and 4 weeks post-intervention\]

  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) using a Class IV pulsed Nd:YAG laser system (wavelength 1064 nm). Treatment parameters: peak power 3000 W, average power 10 W, frequency 1000 Hz (pulsed mode), energy density 12-15 J/cm² per trigger point, 4-6 active myofascial trigger points treated per session, total treatment duration 8-10 minutes per session. Treatment will be administered three times weekly for four weeks (total 12 sessions), combined with a standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization exercises).

Radiation: High-Intensity Laser Therapy (HILT)

Extracorporeal Shockwave Therapy (ESWT)

ACTIVE COMPARATOR

Participants will receive radial extracorporeal shockwave therapy (ESWT) using a pneumatic device (Gymna-Uniphy NV, Bilzen, Belgium). Treatment parameters: energy flux density 0.08-0.12 mJ/mm² (corresponding to device pressure setting 2.0-2.5 bar), frequency 8-10 Hz, approximately 1500 pulses per session delivered to active myofascial trigger points (500 pulses per trigger point). Treatment will be administered once weekly for four weeks (total 4 sessions), combined with a standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization exercises).).

Other: Extracorporeal Shockwave Therapy (ESWT)

Interventions

High-Intensity Laser Therapy (HILT) RADIATION

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)

Extracorporeal Shockwave Therapy (ESWT) OTHER

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

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Faculty of Physical Therapy, Benha University

Cairo, Egypt

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Neck Pain; Agnosia

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• reda K. Abdelrazik, associate professor

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind (Outcome Assessor) Masking Description: Due to the physical nature of the interventions, blinding of treating therapists and participants was not feasible. However, outcome assessors and data analysts remained blinded to group allocation throughout the study. Participants were instructed not to disclose their treatment type during outcome assessments.
• 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: March 30, 2026
• Study Completion: April 5, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)