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RecruitingNCT06084754PEMFUpdated Nov 28, 2023

Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis

An interventional study of pulsed electromagnetic field and Antibiotics in Osteomyelitis, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
5 Years to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Osteomyelitis

Browse trials for

Keywords

  • Osteomyelitis
  • Pulsed Electromagnetic Field
03

In context

Osteomyelitis

105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.

This study's planned enrollment of 20 is below the median of 74 across 60 interventional studies indexed under Osteomyelitis.

Browse Osteomyelitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. All patients suffering from localized osteomyelitis in one or both lower limbs
  2. All patients will be assessed by a physician before starting the study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Patients with immune disorders .
  2. Patients who suffer from any systemic diseases that may interfere with the objectives of the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Group A (Study group)

    pulsed electromagnetic field and medical treatment ( vancomycin IV injection 1gm divided 250mg every 6hours )

    Device: pulsed electromagnetic field · Drug: Antibiotics

  • Active comparator
    Group B(control group)

    medical treatment only (vancomycin IV injection 1gm divided 250mg every 6hours )

    Drug: Antibiotics

Interventions

  • Devicepulsed electromagnetic field

    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.

    Also known as: CRYOMAG PROFESSIONAL.LEVEL,s.r.l

  • DrugAntibiotics

    Vancomycin IV injection 1gm divided 250mg every 6hours

06

What researchers measure

Primary outcomes

  1. Changing of osteomyelitis signs

    through CT scan

    Time frame: pre treatment and post two months of treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2023; primary completion for Dec 2023, 1 month later.

Of 21 interventional studies with no phase under Osteomyelitis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 69. This study's planned 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2023
First posted
Oct 16, 2023
StartEst.
Nov 27, 2023
Primary completionEst.
Dec 30, 2023
CompletionEst.
Feb 2024
Last update
Nov 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06084754
Lead sponsor
Cairo University
Responsible party
Norhan Mohamed Eltayeb (principal investigator, Cairo University) — Principal investigator
First posted
Oct 16, 2023
Start date
Nov 27, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Feb 2024 (estimated)
Last update
Nov 28, 2023

Study contacts

Norhan M. Eltayeb, MSc candidate
Contact
1400534@st.pt.cu.edu.eg
01288053957
Nessrien A. AbdelRashid, Ass. professor
Contact
nessrien.afify@pt.cu.edu.eg
01143872680
Nessrien A. AbdelRashid, Ass.professor
study director · physical therapy, Cairo university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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