Treatment Side EffectsPhase 1PHNCT04185194
Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children
A Phase 1 study testing Lidocaine, pulsed ultrasound and especially designed physical therapy program in people with Treatment Side Effects, run by Cairo University at 1 site in Egypt.
Trial summary
A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the pain and discomfort. It provides local analgesia by blocking the initiation and transmission of impulses. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Treatment Side Effects
- What is being tested?
- Lidocaine, pulsed ultrasound and especially designed physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2019
- Phase
- Phase 1
- 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
- No healthy volunteers
- 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)
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.
Trial locations and contacts
1 site in 1 country.
About this study
A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the pain and discomfort. It provides local analgesia by blocking the initiation and transmission of impulses. Lidocaine topical anesthetic gel allows the use of high concentrations of the anesthetic bases without concern about local irritation, uneven absorption or systemic toxicity (Argoff, 2000 ). So, the aim of this study is to compare between the effect of lidocaine phonophoresis and pulsed ultrasound in myofascial pain syndrome in swimmers children.
Read the detailed description
Fourty five children (athletic swimmers) participated in this study, and were classified into three groups ; First control group A : this group consisted of fifteen children were receiving traditional physical therapy program. Second study group B: this group consisted of fifteen children were receiving pulsed ultrasound in addition to traditional physical therapy program as the same as in group A. Third study group C: this group consisted of fifteen children were receiving lidocaine phonophoresis in addition to traditional physical therapy program as the same as in group A. Treatment program in the three groups applied three times a week for three successive months. The study was done in the outpatient clinic of Ismailiy Sporting Club, Ismailia, Egypt.
- Conditions
- Treatment Side Effects
- Being tested
- Lidocaine, pulsed ultrasound, especially designed physical therapy program
- Keywords
- myofascial pain syndrome, pain quality
- 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.
LidocaineDrug
Also called lidocaine topical
transmission of the drug molecules to the underlying muscles
pulsed ultrasoundDevice
using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain
especially designed physical therapy programOther
by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | received especially designed physical therapy program Receives: Other: especially designed physical therapy program |
| group b | Experimental | received pulsed ultrasound in addition to physical therapy program Receives: Drug: Lidocaine; Device: pulsed ultrasound; Other: especially designed physical therapy program |
| group c | Experimental | received lidocaine phonophoresis in addition to physical therapy program Receives: Drug: Lidocaine; Device: pulsed ultrasound; Other: especially designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 6
measurement of interleukin 6 cncentration in blood plasma
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Side EffectsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abdel Moneim Abo El Roos, Cairo University
- Investigators
- Asser Sallam, PhD, Study director, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185194
- Sponsor's protocol ID
- P.T.REC/012/001708
- Acronym
- PH
- Status last verified
- Dec 2019
- First submitted
- 15 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results of the study design, abstract, conclusion
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children
- ClinicalTrials.gov ID
- NCT04185194
- Acronym / sponsor ID
- PH / P.T.REC/012/001708
- Conditions
- Treatment Side Effects
- Keywords
- myofascial pain syndrome, pain quality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 4 Dec 2019 (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.
A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the pain and discomfort. It provides local analgesia by blocking the initiation and transmission of impulses. Lidocaine topical anesthetic gel allows the use of high concentrations of the anesthetic bases without concern about local irritation, uneven absorption or systemic toxicity (Argoff, 2000 ). So, the aim of this study is to compare between the effect of lidocaine phonophoresis and pulsed ultrasound in myofascial pain syndrome in swimmers children.
Detailed description
Fourty five children (athletic swimmers) participated in this study, and were classified into three groups ; First control group A : this group consisted of fifteen children were receiving traditional physical therapy program. Second study group B: this group consisted of fifteen children were receiving pulsed ultrasound in addition to traditional physical therapy program as the same as in group A. Third study group C: this group consisted of fifteen children were receiving lidocaine phonophoresis in addition to traditional physical therapy program as the same as in group A. Treatment program in the three groups applied three times a week for three successive months. The study was done in the outpatient clinic of Ismailiy Sporting Club, Ismailia, Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Other: especially designed physical therapy programreceived especially designed physical therapy program |
| group b | Experimental | Drug: Lidocaine, Device: pulsed ultrasound, Other: especially designed physical therapy programreceived pulsed ultrasound in addition to physical therapy program |
| group c | Experimental | Drug: Lidocaine, Device: pulsed ultrasound, Other: especially designed physical therapy programreceived lidocaine phonophoresis in addition to physical therapy program |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Age range from 10 to 14 years.
Key exclusion criteria (6 listed)
- • Neurological disorders.
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 |
|---|---|---|
| LidocaineAlso: lidocaine topicaltransmission of the drug molecules to the underlying muscles | Drug | group b, group c |
| pulsed ultrasoundusing thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain | Device | group b, group c |
| especially designed physical therapy programby myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius | Other | group A, group b, group c |
Primary outcome
interleukin 6
Time frame: three months
measurement of interleukin 6 cncentration in blood plasma
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 4 Dec 2019.
- Individual participant dataSharing planned: No. results of the study design, abstract, conclusion
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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.
Asser Sallam, PhD study director
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 Phase 1 study testing Lidocaine, pulsed ultrasound and especially designed physical therapy program in people with Treatment Side Effects, 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 3 inclusion and 6 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 4 Dec 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
interleukin 6 (time frame: three months). 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 4 Dec 2019.