Myofascial Pain Syndrome (MPS)HILT-TRAP StudNCT07352787
High-Intensity Laser Therapy for Trapezius Myofascial Pain (HILT-TRAP Study)
A study testing High-Intensity Laser Therapy in people with Myofascial Pain Syndrome (MPS), run by Neveen Abd El Maksoad Kohaf at 1 site in Iraq.
Trial summary
This study aims to evaluate the effectiveness of optimized High-Intensity Laser Therapy (HILT) compared with sham treatment in patients with trapezius myofascial pain syndrome. Outcomes include pain intensity, cervical range of motion, functional disability, and depressive symptoms measured at baseline… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome (MPS)
- What is being tested?
- High-Intensity Laser Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteIraq
- Study dates
- 10 Mar 2026to 10 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Clinically diagnosed trapezius myofascial pain syndrome
- Duration of symptoms ≥ 4 weeks
- Pain intensity ≥ 4 on NPRS
- Able to provide informed consent
Who cannot join
- Red-flag medical conditions (e.g., malignancy, spinal cord compression)
- Neurological disorders affecting the neck or shoulder
- Cognitive impairment or inability to communicate
- Previous laser therapy to the neck/shoulder region within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Al-Hussein Teaching Hospital
Nasiriyah, Nasiriyah, 64001
Mohammed Ali Hassan Jassim, MSc in physiotherapy, 009647818162160, Mohmdg85@gmail.com
Hussein Ali Hussein, PhD, 009647811593388, hussein.hussein@alayen.edu.iq
About this study
Official title: High-Intensity Laser Therapy for Trapezius Myofascial Pain Syndrome: Effects on Pain, ROM, Function, and Depression A Four-Phase Development, Validation, and Evaluation Study
This study aims to evaluate the effectiveness of optimized High-Intensity Laser Therapy (HILT) compared with sham treatment in patients with trapezius myofascial pain syndrome. Outcomes include pain intensity, cervical range of motion, functional disability, and depressive symptoms measured at baseline, post-intervention, and 16-week follow-up.
Read the detailed description
Myofascial pain syndrome of the trapezius muscle is a common cause of chronic neck and shoulder pain associated with functional limitation and psychological distress. Although High-Intensity Laser Therapy is increasingly used in clinical practice, high-quality evidence regarding its long-term effects and optimal treatment parameters is limited.
This double-blind, randomized, placebo-controlled trial will enroll 104 adults with clinically diagnosed trapezius myofascial pain syndrome. Participants will be randomly assigned to receive either optimized High-Intensity Laser Therapy or sham laser treatment. Outcomes will be assessed at baseline, immediately after the intervention, and at 16-week follow-up. This study aims to provide evidence for a standardized, patient-centered HILT protocol suitable for routine clinical practice.
- Conditions
- Myofascial Pain Syndrome (MPS)
- Being tested
- High-Intensity Laser Therapy, Sham Laser Therapy
- Keywords
- High-Intensity Laser Therapy, Trapezius Myofascial Pain Syndrome, Randomized Controlled Trial, Neck Pain, Physiotherapy
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser TherapyDevice
High-Intensity Laser Therapy will be administered using a class IV therapeutic laser device applied over identified trapezius myofascial trigger points and surrounding muscle tissue. Treatment parameters (wavelength, power output, energy density, and duration) will follow standardized clinical protocols and safety guidelines. Sessions will be delivered by a licensed physical therapist, with participants receiving multiple treatment sessions over the intervention period. The therapy aims to promote analgesia, improve microcirculation, reduce muscle tension, and facilitate tissue healing.
Sham Laser TherapyDevice
Sham laser therapy will be administered using an identical laser device and treatment procedure; however, no therapeutic laser energy will be emitted. The duration, frequency, and therapist interaction will be identical to the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Participants in this arm will receive active High-Intensity Laser Therapy applied to the trapezius muscle region for the treatment of trapezius myofascial pain syndrome. Receives: Device: High-Intensity Laser Therapy |
| Sham Laser Therapy | Placebo comparator | Participants in this arm will receive sham laser therapy applied to the trapezius muscle region. The sham procedure will mimic the appearance and application of active laser therapy without delivering therapeutic laser energy. Receives: Device: Sham Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be evaluated using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: 16-week follow-up
Secondary outcomes (3)
Functional Disability
Neck Disability Index (NDI)
Measured: 16-week follow-up
Cervical Range of Motion
Measured using CROM device
Measured: 16-week follow-up
Depression
Beck Depression Inventory-II (BDI-II)
Measured: 16-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start10 Mar 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome (MPS)Studies 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
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neveen Abd El Maksoad Kohaf
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Responsible party
- Sponsor-investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352787
- Sponsor's protocol ID
- HILT-TMPS-2026-4P-DEVVAL
- Acronym
- HILT-TRAP Stud
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Laser Therapy for Trapezius Myofascial Pain Syndrome: Effects on Pain, ROM, Function, and Depression A Four-Phase Development, Validation, and Evaluation Study
- ClinicalTrials.gov ID
- NCT07352787
- Acronym / sponsor ID
- HILT-TRAP Stud / HILT-TMPS-2026-4P-DEVVAL
- Conditions
- Myofascial Pain Syndrome (MPS)
- Keywords
- High-Intensity Laser Therapy, Trapezius Myofascial Pain Syndrome, Randomized Controlled Trial, Neck Pain, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Neveen Abd El Maksoad KohafUniversity, hospital or other
- Collaborators
- Universiti Kebangsaan Malaysia Medical Centre
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 20 Jan 2026 (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 study aims to evaluate the effectiveness of optimized High-Intensity Laser Therapy (HILT) compared with sham treatment in patients with trapezius myofascial pain syndrome. Outcomes include pain intensity, cervical range of motion, functional disability, and depressive symptoms measured at baseline, post-intervention, and 16-week follow-up.
Detailed description
Myofascial pain syndrome of the trapezius muscle is a common cause of chronic neck and shoulder pain associated with functional limitation and psychological distress. Although High-Intensity Laser Therapy is increasingly used in clinical practice, high-quality evidence regarding its long-term effects and optimal treatment parameters is limited.
This double-blind, randomized, placebo-controlled trial will enroll 104 adults with clinically diagnosed trapezius myofascial pain syndrome. Participants will be randomly assigned to receive either optimized High-Intensity Laser Therapy or sham laser treatment. Outcomes will be assessed at baseline, immediately after the intervention, and at 16-week follow-up. This study aims to provide evidence for a standardized, patient-centered HILT protocol suitable for routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Device: High-Intensity Laser TherapyParticipants in this arm will receive active High-Intensity Laser Therapy applied to the trapezius muscle region for the treatment of trapezius myofascial pain syndrome. |
| Sham Laser Therapy | Placebo comparator | Device: Sham Laser TherapyParticipants in this arm will receive sham laser therapy applied to the trapezius muscle region. The sham procedure will mimic the appearance and application of active laser therapy without delivering therapeutic laser energy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years
- Clinically diagnosed trapezius myofascial pain syndrome
- Duration of symptoms ≥ 4 weeks
- Pain intensity ≥ 4 on NPRS
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Red-flag medical conditions (e.g., malignancy, spinal cord compression)
- Neurological disorders affecting the neck or shoulder
- Cognitive impairment or inability to communicate
- Previous laser therapy to the neck/shoulder region within the last 6 months
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 TherapyHigh-Intensity Laser Therapy will be administered using a class IV therapeutic laser device applied over identified trapezius myofascial trigger points and surrounding muscle tissue. Treatment parameters (wavelength, power output, energy density, and duration) will follow standardized clinical protocols and safety guidelines. Sessions will be delivered by a licensed physical therapist, with participants receiving multiple treatment sessions over the intervention period. The therapy aims to promote analgesia, improve microcirculation, reduce muscle tension, and facilitate tissue healing. | Device | High-Intensity Laser Therapy (HILT) |
| Sham Laser TherapySham laser therapy will be administered using an identical laser device and treatment procedure; however, no therapeutic laser energy will be emitted. The duration, frequency, and therapist interaction will be identical to the active treatment. | Device | Sham Laser Therapy |
Primary outcome
Pain Intensity
Time frame: 16-week follow-up
Pain intensity will be evaluated using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
3 secondary outcomes
Functional Disability
Time frame: 16-week follow-up
Cervical Range of Motion
Time frame: 16-week follow-up
Depression
Time frame: 16-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 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.
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 in people with Myofascial Pain Syndrome (MPS), run by Neveen Abd El Maksoad Kohaf at 1 site in Iraq.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Jan 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 Iraq. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 16-week follow-up). 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 20 Jan 2026.