Effect of Pulsed Electromagnetic Field on Pruritus in Burn Scars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- pain intensity
研究概览
简要总结
This study will be conducted to evaluate the effectiveness of pulsed electromagnetic field therapy in pruritus in patients with burn scars.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
opaque sealed envelope
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
pulsed electromagnetic field therapy
Twenty patients with burn scars will receive pulsed electromagnetic field with standard care three times per weeks for six weeks
干预措施: pulsed electromagnetic field therapy (Other)
pulsed electromagnetic field therapy
Twenty patients with burn scars will receive pulsed electromagnetic field with standard care three times per weeks for six weeks
干预措施: standard care (Other)
standard care
Twenty patients with burn scars will receive standard care three times per weeks for six weeks
干预措施: standard care (Other)
结局指标
主要结局
pain intensity
时间窗: 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.
life disability
时间窗: 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.
次要结局
未报告次要终点
研究者
Asmaa Ibrahim Eliwa Sapa
principle investigator : Asmaa ibrahim eliwa
Cairo University