Neck PainMPSNCT06573775
Evaluation of Pain Quality in Young Swimmers Suffering From Myofascial Pain Syndrome Using Lidocaine Phonophoresis
A study testing pulsed ultrasound, myofascial release and lidocaine phonophoresis in people with Neck Pain, run by New Ismailia National University at 1 site in Egypt.
Trial summary
To evaluate pain quality by pain quality assessment scale (PQAS) using lidocaine phonophoresis on myofascial pain syndrome (MPS) in athletic children. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- pulsed ultrasound, myofascial release and lidocaine phonophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2023to 29 Jul 2024
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range from 10 to 14 years.
- All children have regional neck pain complaint.
- Tenderness in cervical trigger points in the midpoint of the upper border of trapezius muscle, from grade II to grade IV according to tenderness grading scheme (Hubbard and Berkoff, 1993) (Appendix I )
- The diagnosis of an active MTrP in the upper trapezius according to (Ardiçet al . , 2002 and Bruno, 2005):
- Patients suffered from active MTrPs in the upper trapezius.
- Tender spots in one or more palpable taut bands.
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- A typical pattern of referred pain distributed in the ipsilateral, posterolateral cervical paraspinal area, mastoid process or temporal area
- Palpable or visible local twitch response on snapping palpation at the most sensitive spot in the taut band.
- Restricted range of motion in lateral bending of the cervical spine to the opposite side.
- 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 children allowed to practice their regular sport activities.
Who cannot join
- Neurological disorders.
- Dermatological disorders.
- Acute trauma prior to the study.
- Fibromyalgia, systemic disease and drug allergy history were excluded from the study.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pain Quality in Young Swimmers Suffering From Myofascial Pain Syndrome Using Lidocaine Phonophoresis: A Randomized Controlled Trial
To evaluate pain quality by pain quality assessment scale (PQAS) using lidocaine phonophoresis on myofascial pain syndrome (MPS) in athletic children.
Read the detailed description
Forty five males athletic swimmer children (10 to 14 years old) with MPS in the upper trapezius muscle were evaluated before and after treatment. They were randomly divided into three groups, n=15 children each. A (control), B and C (study groups). The three groups received spatial designed physical therapy program. The two study groups received pulsed ultrasound and lidocaine phonophoresis repectively. The duration of treatment was 40 minutes, three times / weeks for three successive months.
- Conditions
- Neck Pain
- Being tested
- pulsed ultrasound, myofascial release, lidocaine phonophoresis
- Keywords
- Myofascial, phonophoresis, pain
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed ultrasoundDevice
treatment of myofacial trigger points with therapeutic ultrasound
myofascial releaseOther
Also called myofascial trigger point realease
manual massage and range of motion exercises
lidocaine phonophoresisDevice
transdermal tranmission of lidocaine molecules via ultrasound
| Study group | Role | What they receive |
|---|---|---|
| control group A | Active comparator | the control group received the traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release, stretching and strengthening of the trapezius muscle Receives: Other: myofascial release |
| study group B | Experimental | received pulsed ultrasound in addition to traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release, range of motion exercises, stretching and strengthening of the trapezius muscle Receives: Device: pulsed ultrasound; Other: myofascial release |
| study group C | Experimental | received lidocaine hydrochloride gel 5%phonophoresis in addition to traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release,range of motion exercises stretching and strengthening of the trapezius muscle Receives: Other: myofascial release; Device: lidocaine phonophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain quality
pain quality assessment scale with zero indication of better outcome and twenty means the worst outcome
Measured: 6 weeks
Secondary outcomes (1)
serum cortisol level
measurement of serum cortisol level
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start5 Jun 2023
- Primary completion10 May 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Ismailia National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Moeim Abo EL Ros, New Ismailia National University
- Investigators
- Mohamed AM El Meligy, MD, Study chair, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573775
- Sponsor's protocol ID
- P.T.REC/012/001708
- Acronym
- MPS
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Quality in Young Swimmers Suffering From Myofascial Pain Syndrome Using Lidocaine Phonophoresis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06573775
- Acronym / sponsor ID
- MPS / P.T.REC/012/001708
- Conditions
- Neck Pain
- Keywords
- Myofascial, phonophoresis, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- New Ismailia National UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 27 Aug 2024 (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.
To evaluate pain quality by pain quality assessment scale (PQAS) using lidocaine phonophoresis on myofascial pain syndrome (MPS) in athletic children.
Detailed description
Forty five males athletic swimmer children (10 to 14 years old) with MPS in the upper trapezius muscle were evaluated before and after treatment. They were randomly divided into three groups, n=15 children each. A (control), B and C (study groups). The three groups received spatial designed physical therapy program. The two study groups received pulsed ultrasound and lidocaine phonophoresis repectively. The duration of treatment was 40 minutes, three times / weeks for three successive months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| control group A | Active comparator | Other: myofascial releasethe control group received the traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release, stretching and strengthening of the trapezius muscle |
| study group B | Experimental | Device: pulsed ultrasound, Other: myofascial releasereceived pulsed ultrasound in addition to traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release, range of motion exercises, stretching and strengthening of the trapezius muscle |
| study group C | Experimental | Other: myofascial release, Device: lidocaine phonophoresisreceived lidocaine hydrochloride gel 5%phonophoresis in addition to traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release,range of motion exercises stretching and strengthening of the trapezius muscle |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age range from 10 to 14 years.
- All children have regional neck pain complaint.
- Tenderness in cervical trigger points in the midpoint of the upper border of trapezius muscle, from grade II to grade IV according to tenderness grading scheme (Hubbard and Berkoff, 1993) (Appendix I )
- The diagnosis of an active MTrP in the upper trapezius according to (Ardiçet al . , 2002 and Bruno, 2005):
- Patients suffered from active MTrPs in the upper trapezius.
Key exclusion criteria (7 listed)
- Neurological disorders.
- Dermatological disorders.
- Acute trauma prior to the study.
- Fibromyalgia, systemic disease and drug allergy history were excluded from the study.
- Having myofascial trigger points injection.
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 |
|---|---|---|
| pulsed ultrasoundtreatment of myofacial trigger points with therapeutic ultrasound | Device | study group B |
| myofascial releaseAlso: myofascial trigger point realeasemanual massage and range of motion exercises | Other | control group A, study group B, study group C |
| lidocaine phonophoresistransdermal tranmission of lidocaine molecules via ultrasound | Device | study group C |
Primary outcome
pain quality
Time frame: 6 weeks
pain quality assessment scale with zero indication of better outcome and twenty means the worst outcome
1 secondary outcome
serum cortisol level
Time frame: 6 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 27 Aug 2024.
- 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.
Mohamed AM El Meligy, MD study chair
Suez Canal 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 pulsed ultrasound, myofascial release and lidocaine phonophoresis in people with Neck Pain, run by New Ismailia National 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 12 inclusion and 7 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 27 Aug 2024. 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 quality (time frame: 6 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 27 Aug 2024.