search
Back to results

Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis (PEMF)

Primary Purpose

Osteomyelitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulsed electromagnetic field
Antibiotics
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteomyelitis focused on measuring Osteomyelitis, Pulsed Electromagnetic Field

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Patients with immune disorders . Patients who suffer from any systemic diseases that may interfere with the objectives of the study.

Sites / Locations

  • Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (Study group)

Group B(control group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changing of osteomyelitis signs
through CT scan

Secondary Outcome Measures

Full Information

First Posted
September 19, 2023
Last Updated
October 12, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT06084754
Brief Title
Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis
Acronym
PEMF
Official Title
Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis : Randomized Control Trail Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteomyelitis
Keywords
Osteomyelitis, Pulsed Electromagnetic Field

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Study group)
Arm Type
Experimental
Arm Description
pulsed electromagnetic field and medical treatment ( vancomycin IV injection 1gm divided 250mg every 6hours )
Arm Title
Group B(control group)
Arm Type
Active Comparator
Arm Description
medical treatment only (vancomycin IV injection 1gm divided 250mg every 6hours )
Intervention Type
Device
Intervention Name(s)
pulsed electromagnetic field
Other Intervention Name(s)
CRYOMAG PROFESSIONAL.LEVEL,s.r.l
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Description
Vancomycin IV injection 1gm divided 250mg every 6hours
Primary Outcome Measure Information:
Title
Changing of osteomyelitis signs
Description
through CT scan
Time Frame
pre treatment and post two months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients with immune disorders . Patients who suffer from any systemic diseases that may interfere with the objectives of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Norhan M. Eltayeb, MSc candidate
Phone
01288053957
Email
1400534@st.pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Nessrien A. AbdelRashid, Ass. professor
Phone
01143872680
Email
nessrien.afify@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nessrien A. AbdelRashid, Ass.professor
Organizational Affiliation
physical therapy, Cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Physical Therapy Cairo University
City
Giza
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis

We'll reach out to this number within 24 hrs