High Intensity LaserNCT06990932
High Intensity Laser vs Instrument-assisted Soft Tissue Mobilization on Trapezius Myofascial Pain Syndrome
A study testing High Intensity Laser, Instrument-assisted Soft Tissue Mobilization and Conventional treatment in people with High Intensity Laser and Instrument Assisted Soft Tissue Mobilization, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study was to 1. Investigate the effect of high-intensity laser therapy versus Instrument-assisted soft tissue mobilization on pain level in patients with myofascial pain syndrome of upper trapezius muscle. 2. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- High Intensity Laser, Instrument Assisted Soft Tissue Mobilization, Trapezius Muscle Strain
- What is being tested?
- High Intensity Laser, Instrument-assisted Soft Tissue Mobilization and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Apr 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient age ranged from 20 to 50 years
- Presence of myofascial trigger points in the upper trapezius muscle
- Having neck discomfort symptoms that were triggered by certain neck positions and by palpating the cervical musculature for at least three months
- Patient willing and able to participate in an exercise program safely
Who cannot join
- medical red flag history (such as tumour, fracture, metabolic diseases, rheumatoid arthritis and osteoporosis)
- Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation.
- If the patient had previous surgery in the neck area (irrespective of the reason for the operation)
- Neck pain accompanied by vertigo caused by vertebra basilar insufficiency or accompanied by non-cervicogenic headaches
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinic of faculty of physical therapy Benha National university
Banhā
About this study
The purpose of the study was to
- Investigate the effect of high-intensity laser therapy versus Instrument-assisted soft tissue mobilization on pain level in patients with myofascial pain syndrome of upper trapezius muscle.
- Investigate the effect of High intensity laser therapy versus Instrument-assisted soft tissue mobilization on ROM in patients with myofascial pain syndrome of upper trapezius muscle
Read the detailed description
Myofascial pain syndrome is a common musculoskeletal pain affecting 30% of patients in primary care. It is characterized by trigger points in the upper trapezius muscle, which is linked to neck and shoulder pain. Non-invasive treatments like exercises, manipulation, and physical agents have been suggested for managing neck pain. Laser therapy, including low-level and high-intensity, has been found effective in reducing pain intensity and improving functional activity. Instrument-assisted soft tissue mobilization is another technique used to treat Myofascial pain syndrome. Instrument-assisted soft tissue mobilization stimulates connective tissue remodeling, resorbing excessive fibrosis, and promoting collagen repair and regeneration. The study aims to investigate the effect of high intensity laser therapy versus Instrument-assisted soft tissue mobilization in treating Myofascial pain syndrome of the upper trapezius muscle.
- Conditions
- High Intensity Laser, Instrument Assisted Soft Tissue Mobilization, Trapezius Muscle Strain, Myofascial Pain Syndrome
- Being tested
- High Intensity Laser, Instrument-assisted Soft Tissue Mobilization, Conventional treatment
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity LaserDevice
The therapeutic dose of laser therapy depends on power density, tissue color, and type. Darker skin may absorb the laser in the epidermal layer, but HILT can pass through without absorption. Research has improved power density and dose, with the World Association of Laser Therapy recommending a 5-7 J/cm2 dose for optimal therapeutic outcomes.
Instrument-assisted Soft Tissue MobilizationOther
Instrument-assisted soft tissue mobilization is a popular alternative to traditional manual therapy techniques, derived from Cyriax cross-friction massage. It uses hard tools to manipulate soft tissue, varying in direction, force, and pattern, and allowing pressure to disperse to underlying tissues. Modern Instrument-assisted soft tissue mobilization instruments vary in material and design, and are used to improve musculoskeletal conditions and outcomes. Patients receive Instrument-assisted soft tissue mobilization with an M2T blade, positioned at a 45° angle, and instructed to apply an ice pack if experiencing burning sensations.
Conventional treatmentOther
conventional physical therapy, which includes ultrasound, isometric neck exercises, chin tucks, stretching of neck muscles, and neck stabilization exercises, were used for groups A, B and C
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Laser | Experimental | this group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month Receives: Device: High Intensity Laser; Other: Conventional treatment |
| Instrument-assisted soft tissue mobilization | Active comparator | this group consists of 20 subjects will receive conventional treatment combined with Instrument-assisted soft tissue mobilization, three times per week for one month Receives: Other: Instrument-assisted Soft Tissue Mobilization; Other: Conventional treatment |
| conventional treatment | Active comparator | this group consists of 20 subjects will receive conventional treatment only, three times per week for one month Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of pain intensity
The Visual Analog Scale is a self-reported pain measurement scale with a 10-cm line labeling extreme pain levels. It is valid, reliable, and suitable for clinical practice, especially for individuals over 18. Studies have shown moderate to strong correlations for VAS validity in pain measurement.
Measured: At baseline and after 1 month
Secondary outcomes (3)
Assessment of change of pressure pain threshold
A pressure algometer is a reliable tool for determining local pressure pain threshold (PPT) in different pain syndromes. It is a force gauge calibrated in kg/cm2 and has a range of 0-10 kg/cm2. A manual pressure algometer will be used to measure pain threshold for upper trapezius fibers, with repeated measurements to improve reliability.
Measured: At baseline and after 1 month
Assessment of change of Cervical range of motion
The CROM device is a lightweight, comfortable, and secure device that adjusts to a patient's head, resembling eyeglasses. It features two independent inclinometers, one in the sagittal and one in the frontal plane, and a third in the horizontal plane, indicating head rotation. The device is easy to use, requires minimal palpation, and is affordable compared to more advanced motion analysis systems.
Measured: At baseline and after 1 month
Assessment of impact of neck pain on quality of life
The Neck Bournemouth Questionnaire (NBQ) is a tool measuring neck pain's impact on daily activities and emotional well-being. It covers seven areas and scores 0 to 70, with higher scores indicating greater disability. The NBQ is sensitive and validated in English, French, Dutch, and Arabic.
Measured: At baseline and after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Feb 2025
- Primary completion15 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity LaserStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Ahmed Abdelmoaty AboHashish, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990932
- Sponsor's protocol ID
- Ahmed-005701
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 25 May 2025
- 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Laser vs Instrument-assisted Soft Tissue Mobilization on Trapezius Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06990932
- Acronym / sponsor ID
- Ahmed-005701
- Conditions
- High Intensity Laser, Instrument Assisted Soft Tissue Mobilization, Trapezius Muscle Strain, Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 25 May 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.
The purpose of the study was to
- Investigate the effect of high-intensity laser therapy versus Instrument-assisted soft tissue mobilization on pain level in patients with myofascial pain syndrome of upper trapezius muscle.
- Investigate the effect of High intensity laser therapy versus Instrument-assisted soft tissue mobilization on ROM in patients with myofascial pain syndrome of upper trapezius muscle
Detailed description
Myofascial pain syndrome is a common musculoskeletal pain affecting 30% of patients in primary care. It is characterized by trigger points in the upper trapezius muscle, which is linked to neck and shoulder pain. Non-invasive treatments like exercises, manipulation, and physical agents have been suggested for managing neck pain. Laser therapy, including low-level and high-intensity, has been found effective in reducing pain intensity and improving functional activity. Instrument-assisted soft tissue mobilization is another technique used to treat Myofascial pain syndrome. Instrument-assisted soft tissue mobilization stimulates connective tissue remodeling, resorbing excessive fibrosis, and promoting collagen repair and regeneration. The study aims to investigate the effect of high intensity laser therapy versus Instrument-assisted soft tissue mobilization in treating Myofascial pain syndrome of the upper trapezius muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Laser | Experimental | Device: High Intensity Laser, Other: Conventional treatmentthis group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month |
| Instrument-assisted soft tissue mobilization | Active comparator | Other: Instrument-assisted Soft Tissue Mobilization, Other: Conventional treatmentthis group consists of 20 subjects will receive conventional treatment combined with Instrument-assisted soft tissue mobilization, three times per week for one month |
| conventional treatment | Active comparator | Other: Conventional treatmentthis group consists of 20 subjects will receive conventional treatment only, three times per week for one month |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient age ranged from 20 to 50 years
- Presence of myofascial trigger points in the upper trapezius muscle
- Having neck discomfort symptoms that were triggered by certain neck positions and by palpating the cervical musculature for at least three months
- Patient willing and able to participate in an exercise program safely
Key exclusion criteria (4 listed)
- medical red flag history (such as tumour, fracture, metabolic diseases, rheumatoid arthritis and osteoporosis)
- Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation.
- If the patient had previous surgery in the neck area (irrespective of the reason for the operation)
- Neck pain accompanied by vertigo caused by vertebra basilar insufficiency or accompanied by non-cervicogenic headaches
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 LaserThe therapeutic dose of laser therapy depends on power density, tissue color, and type. Darker skin may absorb the laser in the epidermal layer, but HILT can pass through without absorption. Research has improved power density and dose, with the World Association of Laser Therapy recommending a 5-7 J/cm2 dose for optimal therapeutic outcomes. | Device | High Intensity Laser |
| Instrument-assisted Soft Tissue MobilizationInstrument-assisted soft tissue mobilization is a popular alternative to traditional manual therapy techniques, derived from Cyriax cross-friction massage. It uses hard tools to manipulate soft tissue, varying in direction, force, and pattern, and allowing pressure to disperse to underlying tissues. Modern Instrument-assisted soft tissue mobilization instruments vary in material and design, and are used to improve musculoskeletal conditions and outcomes. Patients receive Instrument-assisted soft tissue mobilization with an M2T blade, positioned at a 45° angle, and instructed to apply an ice pack if experiencing burning sensations. | Other | Instrument-assisted soft tissue mobilization |
| Conventional treatmentconventional physical therapy, which includes ultrasound, isometric neck exercises, chin tucks, stretching of neck muscles, and neck stabilization exercises, were used for groups A, B and C | Other | High Intensity Laser, Instrument-assisted soft tissue mobilization, conventional treatment |
Primary outcome
Assessment of change of pain intensity
Time frame: At baseline and after 1 month
The Visual Analog Scale is a self-reported pain measurement scale with a 10-cm line labeling extreme pain levels. It is valid, reliable, and suitable for clinical practice, especially for individuals over 18. Studies have shown moderate to strong correlations for VAS validity in pain measurement.
3 secondary outcomes
Assessment of change of pressure pain threshold
Time frame: At baseline and after 1 month
Assessment of change of Cervical range of motion
Time frame: At baseline and after 1 month
Assessment of impact of neck pain on quality of life
Time frame: At baseline and after 1 month
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 25 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Instrument-assisted Soft Tissue Mobilization and Conventional treatment in people with High Intensity Laser and Instrument Assisted Soft Tissue Mobilization, run by Cairo 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 4 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: finished, as of the sponsor's last update on 25 May 2025. 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?
Assessment of change of pain intensity (time frame: At baseline and after 1 month). 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 25 May 2025.