Myofascial Pain SyndromeNCT06845475
Effect of Shock Wave Therapy on Myofascial Pain Syndrome in Adolescent Athletes
A study testing Designed physical therapy program and Extracorporeal shock wave therapy (ESWT) in people with Myofascial Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the effect of extracorporeal shockwave therapy on pain, neck range of motion, and functional activity in adolescent athletes. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Designed physical therapy program and Extracorporeal shock wave therapy (ESWT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2025to 5 May 2025
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ranges from 14 to 18 years.
- All adolescents have regional pain complaint.
- Tenderness in cervical trigger points in the midpoint of the upper border of the trapezius muscle, from grade 2 to grade 4 according to the tenderness grading scheme (Hubbard, 1993) (Appendix II).
- Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle.
- Identification of a palpable taut band, as well as a palpable, and exquisitely tender spot along the length of that taut band.
- All adolescents are allowed to practice their regular sports activities.
Who cannot join
- Dermatological disorders.
- Having myofascial trigger points injection.
- Chronic pain in both sides of the body.
- History of findings of cervical injury whether orthopedic or soft tissue injury.
- Analgesic drugs or NSAIDs during the treatment period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Walaa Abd El Hakeem Abd El Nabi, PhD contact
Egypt1 site
Ismailia Medical Complex
Ismailia
Mohamed Hafez Mohamed, M.Sc, 01201170770, drmohamedhafezpt@gmail.com
About this study
The purpose of the study is to determine the effect of extracorporeal shockwave therapy on pain, neck range of motion, and functional activity in adolescent athletes.
Read the detailed description
Myofascial pain syndrome is a syndrome characterized by pain and accompanying muscle spasms, referred pain patterns, stiffness, and restricted range of motion caused by trigger points on constricted fibers of muscles and/or fasciae. Myofascial pain syndrome is the most common reason for back pain, shoulder pain, tension-type headaches, and regional pains such as facial pain.
Myofascial trigger points (MTrPs) are understood as the morphological correlate of the myofascial pain syndrome (MPS), an acute or chronic muscular pain condition affecting a single muscle or a group of muscles. Active MTrPs are spontaneously painful, while latent MTrPs are only painful upon pressure. MTrP stimulation can also cause referred pain and the characteristic local twitch response.
The main goal of MPS treatment is to break down the vicious circle of "spasm - pain - spasm" and release trigger points. Various physical therapy modalities such as trigger point injection, stretching-spray technique or ultrasound (US), heat packs and transcutaneous electrical nerve stimulation (TENS), and extracorporeal shock wave therapy (ESWT), are used for the treatment of MPS. These modalities inactivate the trigger point with their thermal and mechanical effects.
Due to the lack of research area of extracorporeal shock wave therapy on myofascial pain syndrome on upper trapezius in adolescents' athletes, so the purpose of the study is to know impact of the extracorporeal shock wave therapy on myofascial pain syndrome on upper trapezius in adolescents' athletes.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Designed physical therapy program, Extracorporeal shock wave therapy (ESWT)
- 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.
Designed physical therapy programOther
Both groups will receive a designed physical therapy program, in the form of myofascial trigger points pressure release, stretching of the upper trapezius muscle, strengthening exercises, and infrared radiation for 4 weeks.
Extracorporeal shock wave therapy (ESWT)Other
Adolescents of the experimental group will receive Extracorporeal shock wave therapy with the following parameters; low-level energy radial extracorporeal shock wave by (STORZ MEDICAL Master Pulse MP200), each subject received 3 sessions per week for 4 weeks with 700 impulse/session 400 impulse was applied to tight band and 300 impulses will be applied surrounding the tight band, with frequency [10HZ], resulting in positive energy flux density [EFD] 0.056mJ/mm.
| Study group | Role | What they receive |
|---|---|---|
| Designed physical therapy program | Active comparator | It will consist of 20 adolescents, who will receive a designed physical therapy program for the treatment of Myofascial pain syndrome. Receives: Other: Designed physical therapy program |
| Designed physical therapy program + Extracorporeal shock wave therapy (ESWT) | Experimental | It will consist of 20 adolescents, who will receive the same designed physical therapy program in addition to extracorporeal shock wave therapy (ESWT). Receives: Other: Designed physical therapy program; Other: Extracorporeal shock wave therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain level
By Pain Quality Assessment Scale (PQAS), which help to measure different aspects of pain. For one patient, a pain might feel extremely hot and burning, but not at all dull, while another patient may not experience any burning pain, but feel like their pain is very dull and achy. High test-retest reliability has been observed in both literate and illiterate patients with neuropathic pain, for construct validity, was high in patients with chronic pain conditions. The scale creates a 20- item measures that would be even more useful for assessing neuropathic pain and also would be used to assess pain qualities associated with non-neuropathic pain. PQAS can be scored as individual ratings (20 items), or the PQAS items can be combined into composite scores.
Measured: 4 weeks
Secondary outcomes (7)
Assessment cervical flexion range of motion (ROM)
It will be assessed by the CROM instrument pre and post-treatment. The subject should be seated upright in a straight-back chair with the sacrum against the backrest, thoracic spine away, arms at the sides, and feet flat on the floor. The CROM instrument is positioned like a pair of glasses and secured with Velcro straps. To ensure full cervical flexion, the movement begins with a slight nod to create a double chin (suboccipital flexion) before continuing into full flexion. The sagittal plane meter should be read through its beveled edge for an accurate magnified reading, and the measurement is recorded on the designated sheet.
Measured: 4 weeks
Assessment cervical extension range of motion (ROM)
It will be assessed by the CROM instrument pre and post-treatment. Cervical extension is measured by initiating a slight backward nod (suboccipital extension), followed by further extension until the full range is reached. The obtained measurement is then recorded accordingly.
Measured: 4 weeks
Assessment cervical lateral flexion ROM to the right
It will be assessed by the CROM instrument pre and post-treatment. To prevent rotation during lateral flexion, focus should remain on a fixed point straight ahead. A sagittal plane meter reading of zero confirms a neutral head position, while any deviation on the lateral flexion meter indicates lateral flexion at rest, which should be recorded. Lateral flexion of the head to the right is performed while maintaining level shoulders and avoiding rotation. Shoulder elevation is monitored and corrected manually if needed.
Measured: 4 weeks
Assessment cervical lateral flexion ROM to the left
It will be assessed by the CROM instrument pre and post-treatment. To prevent rotation during lateral flexion, focus should remain on a fixed point straight ahead. A sagittal plane meter reading of zero confirms a neutral head position, while any deviation on the lateral flexion meter indicates lateral flexion at rest, which should be recorded. Lateral flexion of the head to the left is performed while maintaining level shoulders and avoiding rotation. Shoulder elevation is monitored and corrected manually if needed.
Measured: 4 weeks
Assessment cervical rotation ROM to the right
It will be assessed by the CROM instrument plus the magnetic yoke and rotation arm pre and post-treatment. Accurate readings depend on determining magnetic north by observing the red needle on the rotation meter at least four feet from the yoke. The magnetic yoke is positioned on the subject's shoulders with the arrow pointing north. The subject remains seated upright in a straight-back chair with the sacrum against the backrest, thoracic spine away, arms at the sides, and feet flat. The lateral flexion and sagittal plane meters must read zero to ensure a level rotation meter. With the subject facing forward, the rotation meter is adjusted so one pointer aligns with zero. A fixed horizontal line on the wall serves as a visual reference to prevent head tilting. Rotation to the right occurs first, with the left shoulder lightly stabilized to prevent movement.
Measured: 4 weeks
Assessment cervical rotation ROM to the left
It will be assessed by the CROM instrument plus the magnetic yoke and rotation arm pre and post-treatment. Accurate readings depend on determining magnetic north by observing the red needle on the rotation meter at least four feet from the yoke. The magnetic yoke is positioned on the subject's shoulders with the arrow pointing north. The subject remains seated upright in a straight-back chair with the sacrum against the backrest, thoracic spine away, arms at the sides, and feet flat. The lateral flexion and sagittal plane meters must read zero to ensure a level rotation meter. With the subject facing forward, the rotation meter is adjusted so one pointer aligns with zero. A fixed horizontal line on the wall serves as a visual reference to prevent head tilting. Rotation to the left occurs first, with the right shoulder lightly stabilized to prevent movement.
Measured: 4 weeks
Assessment of functional activity of neck
It will be assessed pre and post-treatment using the neck disability index (NDI).The 10 items include effects of pain on personal care activities: lifting, reading, sleeping and the patient level of participation in recreational activities. Each section contains 6 statements representing a different level of severity. Each section is scored on a 0 to 5 scale, with 5 designating the greatest disability. The scores of each section are summated for a total score of 50. The total score is then multiplied by 2 to arrive at percentage score. This value represents the percentage of disability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start25 Feb 2025 (estimated)
- Primary completion25 Apr 2025 (estimated)
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hafez Mohamed, Cairo University
- Investigators
- Nanees Essam Mohamed Salem, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845475
- Sponsor's protocol ID
- P.T.REC/012/005356
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shock Wave Therapy on Myofascial Pain Syndrome in Adolescent Athletes
- ClinicalTrials.gov ID
- NCT06845475
- Acronym / sponsor ID
- P.T.REC/012/005356
- Conditions
- Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (estimated)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 25 Feb 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 is to determine the effect of extracorporeal shockwave therapy on pain, neck range of motion, and functional activity in adolescent athletes.
Detailed description
Myofascial pain syndrome is a syndrome characterized by pain and accompanying muscle spasms, referred pain patterns, stiffness, and restricted range of motion caused by trigger points on constricted fibers of muscles and/or fasciae. Myofascial pain syndrome is the most common reason for back pain, shoulder pain, tension-type headaches, and regional pains such as facial pain.
Myofascial trigger points (MTrPs) are understood as the morphological correlate of the myofascial pain syndrome (MPS), an acute or chronic muscular pain condition affecting a single muscle or a group of muscles. Active MTrPs are spontaneously painful, while latent MTrPs are only painful upon pressure. MTrP stimulation can also cause referred pain and the characteristic local twitch response.
The main goal of MPS treatment is to break down the vicious circle of "spasm - pain - spasm" and release trigger points. Various physical therapy modalities such as trigger point injection, stretching-spray technique or ultrasound (US), heat packs and transcutaneous electrical nerve stimulation (TENS), and extracorporeal shock wave therapy (ESWT), are used for the treatment of MPS. These modalities inactivate the trigger point with their thermal and mechanical effects.
Due to the lack of research area of extracorporeal shock wave therapy on myofascial pain syndrome on upper trapezius in adolescents' athletes, so the purpose of the study is to know impact of the extracorporeal shock wave therapy on myofascial pain syndrome on upper trapezius in adolescents' athletes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Designed physical therapy program | Active comparator | Other: Designed physical therapy programIt will consist of 20 adolescents, who will receive a designed physical therapy program for the treatment of Myofascial pain syndrome. |
| Designed physical therapy program + Extracorporeal shock wave therapy (ESWT) | Experimental | Other: Designed physical therapy program, Other: Extracorporeal shock wave therapy (ESWT)It will consist of 20 adolescents, who will receive the same designed physical therapy program in addition to extracorporeal shock wave therapy (ESWT). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age ranges from 14 to 18 years.
- All adolescents have regional pain complaint.
- Tenderness in cervical trigger points in the midpoint of the upper border of the trapezius muscle, from grade 2 to grade 4 according to the tenderness grading scheme (Hubbard, 1993) (Appendix II).
- Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle.
- Identification of a palpable taut band, as well as a palpable, and exquisitely tender spot along the length of that taut band.
Key exclusion criteria (5 listed)
- Dermatological disorders.
- Having myofascial trigger points injection.
- Chronic pain in both sides of the body.
- History of findings of cervical injury whether orthopedic or soft tissue injury.
- Analgesic drugs or NSAIDs during the treatment 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 |
|---|---|---|
| Designed physical therapy programBoth groups will receive a designed physical therapy program, in the form of myofascial trigger points pressure release, stretching of the upper trapezius muscle, strengthening exercises, and infrared radiation for 4 weeks. | Other | Designed physical therapy program, Designed physical therapy program + Extracorporeal shock wave therapy (ESWT) |
| Extracorporeal shock wave therapy (ESWT)Adolescents of the experimental group will receive Extracorporeal shock wave therapy with the following parameters; low-level energy radial extracorporeal shock wave by (STORZ MEDICAL Master Pulse MP200), each subject received 3 sessions per week for 4 weeks with 700 impulse/session 400 impulse was applied to tight band and 300 impulses will be applied surrounding the tight band, with frequency [10HZ], resulting in positive energy flux density [EFD] 0.056mJ/mm. | Other | Designed physical therapy program + Extracorporeal shock wave therapy (ESWT) |
Primary outcome
Assessment of pain level
Time frame: 4 weeks
By Pain Quality Assessment Scale (PQAS), which help to measure different aspects of pain. For one patient, a pain might feel extremely hot and burning, but not at all dull, while another patient may not experience any burning pain, but feel like their pain is very dull and achy. High test-retest reliability has been observed in both literate and illiterate patients with neuropathic pain, for construct validity, was high in patients with chronic pain conditions. The scale creates a 20- item measures that would be even more useful for assessing neuropathic pain and also would be used to assess pain qualities associated with non-neuropathic pain. PQAS can be scored as individual ratings (20 items), or the PQAS items can be combined into composite scores.
7 secondary outcomes
Assessment cervical flexion range of motion (ROM)
Time frame: 4 weeks
Assessment cervical extension range of motion (ROM)
Time frame: 4 weeks
Assessment cervical lateral flexion ROM to the right
Time frame: 4 weeks
Assessment cervical lateral flexion ROM to the left
Time frame: 4 weeks
Assessment cervical rotation ROM to the right
Time frame: 4 weeks
Assessment cervical rotation ROM to the left
Time frame: 4 weeks
Assessment of functional activity of neck
Time frame: 4 weeks
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 25 Feb 2025.
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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.
Walaa Abd El Hakeem Abd El Nabi, PhD contact
Nanees Essam Mohamed Salem, PhD study chair
Professor, Cairo 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 Designed physical therapy program and Extracorporeal shock wave therapy (ESWT) in people with Myofascial Pain Syndrome, 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 6 inclusion and 5 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 25 Feb 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?
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?
Contact Mohamed Hafez Mohamed, M.Sc (01201170770, drmohamedhafezpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain level (time frame: 4 weeks). 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 Feb 2025.