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PEMF: Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06084754
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2.6
Anticipated Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
double blinded
Primary Purpose:
Treatment
Official Title:
Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis : Randomized Control Trail Study
Anticipated Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (Study group)

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

Device: pulsed 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.
Other Names:
  • CRYOMAG PROFESSIONAL.LEVEL,s.r.l

    • Drug: Antibiotics
    Vancomycin IV injection 1gm divided 250mg every 6hours
    Active Comparator: Group B(control group)

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

    Drug: Antibiotics
    Vancomycin IV injection 1gm divided 250mg every 6hours

    Outcome Measures

    Primary Outcome Measures

    1. Changing of osteomyelitis signs [pre treatment and post two months of treatment]

      through CT scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. Patients with immune disorders .

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Physical Therapy Cairo University Giza Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Nessrien A. AbdelRashid, Ass.professor, physical therapy, Cairo university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norhan Mohamed Eltayeb, principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT06084754
    Other Study ID Numbers:
    • P.T.REC/012/004589
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norhan Mohamed Eltayeb, principal investigator, Cairo University
    Osteomyelitis
    Pulsed Electromagnetic Field
    Additional relevant MeSH terms:
    Osteomyelitis
    Anti-Bacterial Agents

    Study Results

    No Results Posted as of Oct 16, 2023