Myofascial Pain Syndrome of NeckNCT05288933
Instrument-Assisted Soft Tissue Mobilization Versus High Power Pain Threshold Ultrasound For Trapezius Myofascial Trigger Points
A study testing Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound in people with Myofascial Pain Syndrome of Neck, run by Cairo University at 1 site in Egypt.
Trial summary
the purpose of this trial is to compare the effectiveness of instrument-assisted soft tissue mobilization and high power pain threshold ultrasound on pain intensity, pressure pain threshold (PPT), neck range of motion, and neck function in participants with upper trapezius myofascial trigger points. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Myofascial Pain Syndrome of Neck
- What is being tested?
- Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound
- 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
- 9 Mar 2022to 12 Jun 2022
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: Having at least 1 active trigger point in bilateral upper trapezius muscles We will use a recommended diagnostic criterion to find active MTrPs which is:
The presence of a palpable taut band in the skeletal muscle, The presence of a hypersensitive spot in the taut band, Local twitch response provoked by snapping palpation Production of referred pain pattern in response to the compression of tender spots Spontaneous presence of typically referred pain pattern.
- A duration of symptoms of 2-4 weeks.
- Age between 25 and 40 years.
- Having a normal neurological examination result.
- Not having any evidence of infection or inflammation in laboratory tests.
Exclusion Criteria:- Existence of cervical disc hernia, advanced cervical osteoarthritis, radiculopathy, or myelopathy.
- Having trigger point injection or physical therapy in the last 6 months.
- Having a rheumatologic disease, such as fibromyalgia, rheumatoid arthritis, and spondyloarthritis, or hormonal diseases, such as hypothyroidism, hyperthyroidism, or hyperparathyroidism.
- Existence of kyphosis, scoliosis, forward head posture, or cervical-genic headache.
- History of spine surgery.
- Having a cardiovascular problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Instrument-Assisted Soft Tissue Mobilization Versus High Power Pain Threshold Ultrasound In Management Of Upper Trapezius Myofascial Trigger Points: Randomized Controlled Trial
the purpose of this trial is to compare the effectiveness of instrument-assisted soft tissue mobilization and high power pain threshold ultrasound on pain intensity, pressure pain threshold (PPT), neck range of motion, and neck function in participants with upper trapezius myofascial trigger points.
Read the detailed description
Myofascial trigger points (MTPs) are hyperirritable, palpable nodules that form along with taut bands of muscle fibers. The trapezius is the muscle that is most commonly affected. MTPs can have a considerable impact on a person's daily activities and ability to work. Stretching exercises, ultrasound, massage, kinesiology taping, trigger point release, dry needling, laser, ischemic compression treatment, and high-power pain threshold ultrasound can all be used in a physical therapy program for myofascial pain and trigger points. There were previous studies on the effect of instrument-assisted soft tissue mobilization (IASTM) on upper trapezius myofascial trigger points that have shown positive effects such as reduction in pain level, improved neck function, and range of motion, increased activity level, and increased pressure pain threshold. There have been previous studies on the effect of high-power pain threshold ultrasound on upper trapezius trigger points that have shown a reduction in pain level, increased activity level, and increased pressure pain threshold. However till now, there is no study comparing the therapeutic potential of HPPT US and IASTM on upper trapezius trigger points, This study is conducted to compare the effect of instrument-assisted soft tissue mobilization (IASTM) and high-power pain threshold ultrasound ( HPPT US ) on upper trapezius trigger points. : Sixty participants ranging in age from 25 to 40 years old, from both genders, were diagnosed with active MTPs in the upper fibers of the trapezius muscle bilaterally. Participants were randomly allocated to the following three groups using sealed envelopes. Group (A) 20 participants received conventional physical therapy. Group (B) 20 participants received IASTM and conventional physical therapy. Group (C) 20 participants received HPPT US and conventional physical therapy for two weeks, twice per week.
- Conditions
- Myofascial Pain Syndrome of Neck
- Being tested
- Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument assisted soft tissue mobilization ( IASTM ) and UltrasoundDevice
Also called Ultrasound
Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment for the myofascial limitation that is based on James Cyriax's rationale.
High-power pain threshold ultrasound is a noninvasive approach used in myofascial pain syndrome ( MPS) treatment, and it has no serious adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) conventional physical therapy | Active comparator | 20 participants will receive conventional physical therapy.TENS, the frequency of the current is 100 Hz and the duty cycle is 250 microseconds, three times per week for 4 weeks. Ultrasound waves, frequency 1 MHz with intensity 1 W/cm2, a pulsed mode for 5 minutes, three times per week for 4 weeks, passive stretching, and isometric exercises three times per week for 4 weeks. Receives: Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound |
| Group (B )IASTM and conventional physical therapy | Experimental | 20 participants will receive Instrument-Assisted Soft Tissue Mobilization (IASTM) and conventional physical therapy, the M2T blade will be used to find the exact areas of restriction in the upper trapezius. Then the M2T blade will be used, at an angle of 45 and using treatment planes 1, 2, and 3, to apply slow strokes along with the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 3 min. This procedure will be repeated twice a week for four weeks Receives: Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound |
| Group (C) HPPT US and conventional physical therapy | Experimental | 20 participants will receive High Power Pain Threshold Ultrasound (HPPT US) and conventional physical therapy. For the HPPT US, ultrasound waves will be applied to trigger points of the upper trapezius in continuous mode, and the power of ultrasound will first increase to the threshold pain level at intensity (1.5-2 W/cm) according to the patient for 4-5 seconds with the probe placed directly on the trigger point and held motionlessly and then reduced to one-half of that intensity for15 seconds with the probe placed directly on the trigger point and move in a circular motion and repeat this three times. This procedure will be repeated twice a week for two weeks Receives: Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured by the Visual Analogue Scale (VAS). It consists of a horizontal or vertical line, usually 10 cm long. The extremes of the line are labeled as "no pain" and "worst pain"
3-Neck Range of motion : by Cervical ROM 3- Neck function: by Arabic version of the Neck Disability
Measured: four weeks
Pressure pain threshold (PPT)
Pressure pain threshold (PPT) will be measured by a Pressure Algometer.
Measured: four weeks
Neck Range of motion
Neck Range of motion will be measured by Cervical ROM
Measured: four weeks
Neck function
Neck function will be measured by the Arabic version of the Neck Disability Index (ANDI). A total score of 0-4 indicated no disability. A score of 5-14 indicated mild disability, a score of 15-24 indicated moderate disability, a score of 25-34 indicated severe disability, and a score of 35 or greater indicated complete disability
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start9 Mar 2022
- Primary completion12 Jun 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome of NeckStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Kamel Ibrahim El sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288933
- Sponsor's protocol ID
- P.T.REC/012/003544
- Status last verified
- Jan 2023
- First submitted
- 11 Mar 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument-Assisted Soft Tissue Mobilization Versus High Power Pain Threshold Ultrasound In Management Of Upper Trapezius Myofascial Trigger Points: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05288933
- Acronym / sponsor ID
- P.T.REC/012/003544
- Conditions
- Myofascial Pain Syndrome of Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 21 Mar 2022 (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 this trial is to compare the effectiveness of instrument-assisted soft tissue mobilization and high power pain threshold ultrasound on pain intensity, pressure pain threshold (PPT), neck range of motion, and neck function in participants with upper trapezius myofascial trigger points.
Detailed description
Myofascial trigger points (MTPs) are hyperirritable, palpable nodules that form along with taut bands of muscle fibers. The trapezius is the muscle that is most commonly affected. MTPs can have a considerable impact on a person's daily activities and ability to work. Stretching exercises, ultrasound, massage, kinesiology taping, trigger point release, dry needling, laser, ischemic compression treatment, and high-power pain threshold ultrasound can all be used in a physical therapy program for myofascial pain and trigger points. There were previous studies on the effect of instrument-assisted soft tissue mobilization (IASTM) on upper trapezius myofascial trigger points that have shown positive effects such as reduction in pain level, improved neck function, and range of motion, increased activity level, and increased pressure pain threshold. There have been previous studies on the effect of high-power pain threshold ultrasound on upper trapezius trigger points that have shown a reduction in pain level, increased activity level, and increased pressure pain threshold. However till now, there is no study comparing the therapeutic potential of HPPT US and IASTM on upper trapezius trigger points, This study is conducted to compare the effect of instrument-assisted soft tissue mobilization (IASTM) and high-power pain threshold ultrasound ( HPPT US ) on upper trapezius trigger points. : Sixty participants ranging in age from 25 to 40 years old, from both genders, were diagnosed with active MTPs in the upper fibers of the trapezius muscle bilaterally. Participants were randomly allocated to the following three groups using sealed envelopes. Group (A) 20 participants received conventional physical therapy. Group (B) 20 participants received IASTM and conventional physical therapy. Group (C) 20 participants received HPPT US and conventional physical therapy for two weeks, twice per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) conventional physical therapy | Active comparator | Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound20 participants will receive conventional physical therapy.TENS, the frequency of the current is 100 Hz and the duty cycle is 250 microseconds, three times per week for 4 weeks. Ultrasound waves, frequency 1 MHz with intensity 1 W/cm2, a pulsed mode for 5 minutes, three times per week for 4 weeks, passive stretching, and isometric exercises three times per week for 4 weeks. |
| Group (B )IASTM and conventional physical therapy | Experimental | Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound20 participants will receive Instrument-Assisted Soft Tissue Mobilization (IASTM) and conventional physical therapy, the M2T blade will be used to find the exact areas of restriction in the upper trapezius. Then the M2T blade will be used, at an angle of 45 and using treatment planes 1, 2, and 3, to apply slow strokes along with the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 3 min. This procedure will be repeated twice a week for four weeks |
| Group (C) HPPT US and conventional physical therapy | Experimental | Device: Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound20 participants will receive High Power Pain Threshold Ultrasound (HPPT US) and conventional physical therapy. For the HPPT US, ultrasound waves will be applied to trigger points of the upper trapezius in continuous mode, and the power of ultrasound will first increase to the threshold pain level at intensity (1.5-2 W/cm) according to the patient for 4-5 seconds with the probe placed directly on the trigger point and held motionlessly and then reduced to one-half of that intensity for15 seconds with the probe placed directly on the trigger point and move in a circular motion and repeat this three times. This procedure will be repeated twice a week for two weeks |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Instrument assisted soft tissue mobilization ( IASTM ) and UltrasoundAlso: UltrasoundInstrument-assisted soft tissue mobilization (IASTM) is a popular treatment for the myofascial limitation that is based on James Cyriax's rationale. High-power pain threshold ultrasound is a noninvasive approach used in myofascial pain syndrome ( MPS) treatment, and it has no serious adverse effects. | Device | Group (A) conventional physical therapy, Group (B )IASTM and conventional physical therapy, Group (C) HPPT US and conventional physical therapy |
Primary outcome
Pain intensity
Time frame: four weeks
Pain intensity will be measured by the Visual Analogue Scale (VAS). It consists of a horizontal or vertical line, usually 10 cm long. The extremes of the line are labeled as "no pain" and "worst pain" 3-Neck Range of motion : by Cervical ROM 3- Neck function: by Arabic version of the Neck Disability
Pressure pain threshold (PPT)
Time frame: four weeks
Pressure pain threshold (PPT) will be measured by a Pressure Algometer.
Neck Range of motion
Time frame: four weeks
Neck Range of motion will be measured by Cervical ROM
Neck function
Time frame: four weeks
Neck function will be measured by the Arabic version of the Neck Disability Index (ANDI). A total score of 0-4 indicated no disability. A score of 5-14 indicated mild disability, a score of 15-24 indicated moderate disability, a score of 25-34 indicated severe disability, and a score of 35 or greater indicated complete disability
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 18 Jan 2023.
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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 Instrument assisted soft tissue mobilization ( IASTM ) and Ultrasound in people with Myofascial Pain Syndrome of Neck, 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?
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 18 Jan 2023. 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?
Pain intensity (time frame: four weeks). The study lists 4 primary outcomes in all. 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 18 Jan 2023; AzTrials last refreshed its copy on 2 Nov 2026.