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Myofascial Pain Syndrome - NeckNCT07176039

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

A study testing High-Intensity Laser Therapy (HILT) and Extracorporeal Shockwave Therapy (ESWT) in people with Myofascial Pain Syndrome - Neck, run by MTI University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Myofascial Pain Syndrome - Neck
What is being tested?
High-Intensity Laser Therapy (HILT) and Extracorporeal Shockwave Therapy (ESWT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
10 Oct 2025to 5 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Physical Therapy, Benha University

    Cairo

Other trials in Egypt

About this study

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.

Read the detailed description

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.

Being tested
High-Intensity Laser Therapy (HILT), Extracorporeal Shockwave Therapy (ESWT)
Keywords
Myofascial Pain Syndrome, High-Intensity Laser Therapy, Extracorporeal Shockwave Therapy, Cervical Pain, Physical Therapy, Pain Management
Medical subject headings
Myofascial Pain Syndromes, Neck Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT07176039
Study groupRoleWhat they receive
High-Intensity Laser Therapy (HILT)ExperimentalParticipants 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).
Receives: Radiation: High-Intensity Laser Therapy (HILT)
Extracorporeal Shockwave Therapy (ESWT)Active comparatorParticipants 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).).
Receives: Other: Extracorporeal Shockwave Therapy (ESWT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

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

Secondary outcomes (3)
  1. Pressure Pain Threshold (PPT) as measured by pressure algometer

    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.

    Measured: Baseline and 4 weeks post-treatment

  2. Neck Disability Index (NDI)

    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.

    Measured: Baseline and 4 weeks post-treatment

  3. Cervical Range of Motion (ROM)

    Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start10 Oct 2025
  3. Primary completion30 Mar 2026
  4. Study completion5 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176039
Sponsor's protocol ID
PT.BU.EC.23
Status last verified
May 2026
First submitted
1 Sep 2025
Last updated
12 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High-Intensity Laser Therapy (HILT) and Extracorporeal Shockwave Therapy (ESWT) in people with Myofascial Pain Syndrome - Neck, run by MTI University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale for Pain Intensity (time frame: Baseline and 4 weeks after intervention (post-treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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