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Not yet recruiting NCT07443358

Effect of Pulsed Electromagnetic Field on Pruritus in Burn Scars

No phase Interventional Burn Scar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pulsed electromagnetic field therapy, standard care.
Who it may be relevant to
Registry conditions: Burn Scar. Basic parameters: 25 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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 .

Interventions

  • Other pulsed electromagnetic field therapy
    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
  • Other 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.

Primary outcome measures

  • pain intensity [Time frame: up to 6 weeks]
  • life disability [Time frame: up to 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07443358 · P.T.REC/012/005747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗