NCT07443358

Brief Summary

This study will be conducted to evaluate the effectiveness of pulsed electromagnetic field therapy in pruritus in patients with burn scars.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

burn scarprurituspulsed electromagnetic field

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    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

    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

Study Arms (2)

pulsed electromagnetic field therapy

EXPERIMENTAL

Twenty patients with burn scars will receive pulsed electromagnetic field with standard care three times per weeks for six weeks

Other: pulsed electromagnetic field therapyOther: standard care

standard care

ACTIVE COMPARATOR

Twenty patients with burn scars will receive standard care three times per weeks for six weeks

Other: standard care

Interventions

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

pulsed electromagnetic field therapy

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.

pulsed electromagnetic field therapystandard care

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pruritus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Asmaa Eliwa, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: pulsed electromagnetic field and standard care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : Asmaa ibrahim eliwa

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 2, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02