- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443358
Effect of Pulsed Electromagnetic Field on Pruritus in Burn Scars (PEM)
February 25, 2026 updated by: Asmaa Ibrahim Eliwa Sapa, Cairo University
This study will be conducted to evaluate the effectiveness of pulsed electromagnetic field therapy in pruritus in patients with burn scars.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Burn injuries are among the most devastating and complex forms of trauma, often requiring prolonged medical care and rehabilitation.
These injuries can cause substantial damage to the skin and underlying tissues, leading to acute complications such as infection, fluid loss, and metabolic dysregulation.
However, the long-term consequences of burn injuries extend beyond the initial trauma, significantly affecting survivors' physical and psychological well-being .The pathophysiology of burn scar pruritus is complex and multifactorial, involving a combination of nerve regeneration, inflammation, and abnormal scar tissue remodeling.
During the healing process, damaged nerve fibers regenerate in an unorganized manner, leading to hyperexcitability and an increased sensation of itch.
This aberrant nerve regrowth is thought to be a key driver of neuropathic itch in burn scars.
Evidence suggests that PEMF therapy may influence nerve signaling pathways involved in neuropathic and inflammatory itch.
By addressing both neural and inflammatory components, PEMF therapy offers a novel mechanism of action that could be particularly beneficial for burn survivors.
However, its efficacy in the context of burn scar pruritus has not been rigorously evaluated, highlighting the need for clinical research .
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Asmaa Eliwa, master
- Phone Number: 01150761961
- Email: dr.asmaa1812@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 25-40 years.
- Patients with second and third-degree burn scars sustained at least 3 months prior to enrollment.
- Patients experiencing a pruritus score ≥ 5 on the Visual Analog Scale (VAS).
- Patients who have not undergone prior PEMF therapy or other physical therapy interventions for pruritus in the past 3 months.
Exclusion Criteria:
- Patients with cardiac pacemakers, implanted defibrillators, or other electronic medical devices.
- Pregnant or lactating women.
- Patients with uncontrolled systemic diseases (e.g., diabetes, hypertension) or active skin infections.
- Patients with psychological disorders that would interfere with their ability to adhere to the treatment protocol.
- Patients with allergic reaction to food or drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pulsed electromagnetic field therapy
Twenty patients with burn scars will receive pulsed electromagnetic field with standard care three times per weeks for six weeks
|
The pulsed electromagnetic field applicator will be positioned 2 cm above the affected burn scar area, ensuring full coverage of the scar with Frequency: 27.12 MHz, Pulse duration: 65 microseconds, and Intensity: 20 Gauss. the patients will receive also standard care
the patients will receive standard care in the form of Application of topical emollients (e.g., silicone-based creams) twice daily to maintain hydration, Moisturizing skin care routines to prevent dryness and irritation, and Gentle scar massage for 10 minutes daily to improve scar pliability.
|
|
Active Comparator: standard care
Twenty patients with burn scars will receive standard care three times per weeks for six weeks
|
the patients will receive standard care in the form of Application of topical emollients (e.g., silicone-based creams) twice daily to maintain hydration, Moisturizing skin care routines to prevent dryness and irritation, and Gentle scar massage for 10 minutes daily to improve scar pliability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: up to 6 weeks
|
The Visual Analog Scale (VAS) will be used to measure the intensity of pruritus experienced by participants.
The scale consists of a 10 cm horizontal line where 0 cm represents "No itch at all," and 10 cm represents "The worst itch imaginable."
Participants will be asked to place a vertical mark on the line corresponding to the severity of their pruritus.
The distance from the left end of the scale to the mark, measured in centimeters, will represent the participant's itching score, ranging from 0 to 10.
|
up to 6 weeks
|
|
life disability
Time Frame: up to 6 weeks
|
The ItchyQoL questionnaire will evaluate the impact of pruritus on participants' quality of life across three domains: symptoms, functional limitations, and emotional well-being.
It is a 22-item self-administered tool scored on a 5-point Likert scale, with responses ranging from 1 (Not at all) to 5 (Extremely).
Higher scores indicate a greater negative impact of itch on quality of life, with total scores ranging from 22 to 110.
Subdomain scores will also be calculated to provide a detailed analysis of how itch affects daily activities and emotional well-being.The assessment time for completing the ItchyQoL is typically 5-10 minutes, depending on the patient's literacy level and familiarity with self-reported questionnaires.
|
up to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 2, 2026
Study Record Updates
Last Update Posted (Actual)
March 2, 2026
Last Update Submitted That Met QC Criteria
February 25, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005747
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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