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.
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)
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
- Conditions
- Myofascial Pain Syndrome - Neck
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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).). Receives: Other: Extracorporeal Shockwave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted16 Sep 2025
- Study start10 Oct 2025
- Primary completion30 Mar 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome - NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reda abd elrazik, Benha University
- Investigators
- reda K. Abdelrazik, associate professor, Principal investigator, Benha University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between High-Intensity Laser Therapy and Extracorporeal Shockwave Therapy in the Treatment of Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT07176039
- Acronym / sponsor ID
- PT.BU.EC.23
- Conditions
- Myofascial Pain Syndrome - Neck
- Keywords
- Myofascial Pain Syndrome, High-Intensity Laser Therapy, Extracorporeal Shockwave Therapy, Cervical Pain, Physical Therapy, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Radiation: High-Intensity Laser Therapy (HILT)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). |
| Extracorporeal Shockwave Therapy (ESWT) | Active comparator | Other: Extracorporeal Shockwave Therapy (ESWT)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).). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Laser Therapy (HILT)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. | Radiation | High-Intensity Laser Therapy (HILT) |
| Extracorporeal Shockwave Therapy (ESWT)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). | Other | Extracorporeal Shockwave Therapy (ESWT) |
Primary outcome
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]
3 secondary outcomes
Pressure Pain Threshold (PPT) as measured by pressure algometer
Time frame: Baseline and 4 weeks post-treatment
Neck Disability Index (NDI)
Time frame: Baseline and 4 weeks post-treatment
Cervical Range of Motion (ROM)
Time frame: Baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
reda K. Abdelrazik, associate professor principal investigator
Benha University
1 site in 1 country: see every site and its status.
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.