Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis

NCT ID: NCT06084754

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-02-29

Brief Summary

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

Detailed Description

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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

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Osteomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double blinded

Study Groups

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Group A (Study group)

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

Group Type EXPERIMENTAL

pulsed electromagnetic field

Intervention Type DEVICE

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.

Antibiotics

Intervention Type DRUG

Vancomycin IV injection 1gm divided 250mg every 6hours

Group B(control group)

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

Group Type ACTIVE_COMPARATOR

Antibiotics

Intervention Type DRUG

Vancomycin IV injection 1gm divided 250mg every 6hours

Interventions

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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.

Intervention Type DEVICE

Antibiotics

Vancomycin IV injection 1gm divided 250mg every 6hours

Intervention Type DRUG

Other Intervention Names

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CRYOMAG PROFESSIONAL.LEVEL,s.r.l

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Norhan Mohamed Eltayeb

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nessrien A. AbdelRashid, Ass.professor

Role: STUDY_DIRECTOR

physical therapy, Cairo university

Locations

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Physical Therapy Cairo University

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Norhan M. Eltayeb, MSc candidate

Role: CONTACT

01288053957

Nessrien A. AbdelRashid, Ass. professor

Role: CONTACT

01143872680

Other Identifiers

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P.T.REC/012/004589

Identifier Type: -

Identifier Source: org_study_id