OsteomyelitisPEMFNCT06084754
Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis
A study testing pulsed electromagnetic field and Antibiotics in people with Osteomyelitis, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- pulsed electromagnetic field and Antibiotics
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2023to Feb 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients suffering from localized osteomyelitis in one or both lower limbs
- All patients will be assessed by a physician before starting the study procedures.
Who cannot join
- Patients with immune disorders .
- Patients who suffer from any systemic diseases that may interfere with the objectives of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis : Randomized Control Trail Study
This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.
Read the detailed description
Twenty (11 girls, 9 boys) patients will participate in this study. Their ages ranged from 5 to 16 years. They will randomly divide into two groups. Group A ( study group) will receive pulsed electromagnetic field in addition to medical treatment three times per week for two months , Group B(control group ) will receive medical treatment only.
- Conditions
- Osteomyelitis
- Being tested
- pulsed electromagnetic field, Antibiotics
- Keywords
- Osteomyelitis, Pulsed Electromagnetic Field
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed electromagnetic fieldDevice
Also called CRYOMAG PROFESSIONAL.LEVEL,s.r.l
pulsed electromagnetic field will be over the site of osteomyelitis where patient in supine lying position. the treatment parameters will be set as10 HZ frequency , 20 gauss amplitude, duration about 120 minutes.
AntibioticsDrug
Vancomycin IV injection 1gm divided 250mg every 6hours
| Study group | Role | What they receive |
|---|---|---|
| Group A (Study group) | Experimental | pulsed electromagnetic field and medical treatment ( vancomycin IV injection 1gm divided 250mg every 6hours ) Receives: Device: pulsed electromagnetic field; Drug: Antibiotics |
| Group B(control group) | Active comparator | medical treatment only (vancomycin IV injection 1gm divided 250mg every 6hours ) Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing of osteomyelitis signs
through CT scan
Measured: pre treatment and post two months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start27 Nov 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Mohamed Eltayeb, Cairo University
- Investigators
- Nessrien A. AbdelRashid, Ass.professor, Study director, physical therapy, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084754
- Sponsor's protocol ID
- P.T.REC/012/004589
- Acronym
- PEMF
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis : Randomized Control Trail Study
- ClinicalTrials.gov ID
- NCT06084754
- Acronym / sponsor ID
- PEMF / P.T.REC/012/004589
- Conditions
- Osteomyelitis
- Keywords
- Osteomyelitis, Pulsed Electromagnetic Field
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Nov 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 16 Oct 2023 (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.
This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.
Detailed description
Twenty (11 girls, 9 boys) patients will participate in this study. Their ages ranged from 5 to 16 years. They will randomly divide into two groups. Group A ( study group) will receive pulsed electromagnetic field in addition to medical treatment three times per week for two months , Group B(control group ) will receive medical treatment only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Study group) | Experimental | Device: pulsed electromagnetic field, Drug: Antibioticspulsed electromagnetic field and medical treatment ( vancomycin IV injection 1gm divided 250mg every 6hours ) |
| Group B(control group) | Active comparator | Drug: Antibioticsmedical treatment only (vancomycin IV injection 1gm divided 250mg every 6hours ) |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All patients suffering from localized osteomyelitis in one or both lower limbs
- All patients will be assessed by a physician before starting the study procedures.
Key exclusion criteria (2 listed)
- Patients with immune disorders .
- Patients who suffer from any systemic diseases that may interfere with the objectives of the study.
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 electromagnetic fieldAlso: CRYOMAG PROFESSIONAL.LEVEL,s.r.lpulsed electromagnetic field will be over the site of osteomyelitis where patient in supine lying position. the treatment parameters will be set as10 HZ frequency , 20 gauss amplitude, duration about 120 minutes. | Device | Group A (Study group) |
| AntibioticsVancomycin IV injection 1gm divided 250mg every 6hours | Drug | Group A (Study group), Group B(control group) |
Primary outcome
Changing of osteomyelitis signs
Time frame: pre treatment and post two months of treatment
through CT scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Nessrien A. AbdelRashid, Ass.professor study director
physical therapy, 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 pulsed electromagnetic field and Antibiotics in people with Osteomyelitis, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norhan M. Eltayeb, MSc candidate (01288053957, 1400534@st.pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing of osteomyelitis signs (time frame: pre treatment and post two months of treatment). 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 28 Nov 2023.