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NCT Number: NCT07176039

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

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.

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Key information

Conditions

Myofascial Pain Syndrome - Neck Agnosia Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neck Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Benha University

Cairo, Egypt

About this study

This randomized single-blind controlled trial aims to compare the efficacy of High-Intensity Laser Therapy (HILT) and Extracorporeal Shockwave Therapy (ESWT) in managing patients with myofascial pain syndrome (MPS) of the upper trapezius/cervical region. Forty adults (20-45 years) diagnosed with MPS according to Travell and Simons' criteria will be randomly allocated (1:1) to either:

  • HILT Group: Class IV pulsed Nd:YAG laser (1064 nm), peak power 3000 W, average power 10 W, frequency 1000 Hz, energy density 12-15 J/cm² per trigger point, 3 sessions/week × 4 weeks (12 total sessions).
  • ESWT Group: Radial extracorporeal shockwave therapy, energy flux density 0.08-0.12 mJ/mm², frequency 8-10 Hz, ~1500 pulses/session, 1 session/week × 4 weeks (4 total sessions).

Both groups receive an identical standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization). Primary outcome: pain intensity (Numeric Pain Rating Scale). Secondary outcomes: pressure pain threshold (digital algometer), Neck Disability Index, and active cervical range of motion (CROM device). Assessments at baseline and week 4. The study is conducted at Faculty of Physical Therapy, Benha University, Egypt.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Numeric Pain Rating Scale for Pain Intensity

    Time frame: Baseline and 4 weeks after intervention (post-treatment)

    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]

Secondary outcomes

  1. Pressure Pain Threshold (PPT) as measured by pressure algometer

    Time frame: Baseline and 4 weeks post-treatment

    The pressure pain threshold (PPT) will be assessed using a digital pressure algometer (in kg/cm² or kPa) applied perpendicularly to active myofascial trigger points in the upper trapezius. The point at which the sensation changes from pressure to pain is recorded. Higher values indicate increased pain tolerance. Measurements will be taken at baseline and post-treatment.

  2. Neck Disability Index (NDI)

    Time frame: Baseline and 4 weeks post-treatment

    Functional disability will be assessed using the Neck Disability Index (NDI), a 10-item self-reported questionnaire scored from 0 to 50, where higher scores indicate greater disability. The primary metric is the mean change from baseline to post-treatment.

  3. Cervical Range of Motion (ROM)

    Time frame: Baseline, 4 weeks

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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