Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale
研究概览
简要总结
This is a study evaluating the Scrambler Therapy device as a non-invasive treatment for neuropathic pain in pediatric oncology patients with metastatic bone disease. The primary goal is to assess changes in pain intensity and medication use, aiming to improve quality of life and reduce reliance on systemic pain medications.
详细描述
Eligible participants (ages 5-26) will undergo 5 to 10 therapy sessions over 1-2 weeks, with pain assessed before and after each session using age-appropriate scales. Additional assessments include the PainDETECT questionnaire and follow-ups at 1, 3, and 6 months to evaluate durability of pain relief and changes in medication use.
The study will enroll up to 70 participants over 5 years, with an expected evaluable sample size of 60. Statistical analyses will compare pre- and post-treatment pain scores, track pain trends across sessions, and assess long-term outcomes. Participants will continue receiving routine care, and therapy will be adjusted based on individual responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to verbalize pain scores
- •Oncology patients with acute and/or chronic pain
排除标准
- •Patients with Implantable Devices
- •Pregnancy
- •A history of myocardial infarction or ischemic heart disease within the past six months
- •History of severe heart arrhythmia or equivalent heart disease
- •Open Wounds or Infections at site of electrode placement
- •A history of intolerance to transcutaneous electronic nerve stimulation
研究组 & 干预措施
Treatment - Scrambler Therapy MC-5A Device
Surface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations.
干预措施: Scrambler Therapy MC-5A Device (Device)
结局指标
主要结局
Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale
时间窗: Prior to first therapy session and immediately following last therapy session
The primary outcome is the change in self-reported pain intensity from baseline (prior to the first Scrambler Therapy session) to the post-final Scrambler Therapy session as measured by Numerical Rating Scale (NRS) or Wong-Baker Faces Pain Scale. The patients will rate pain using one of these scales at the beginning and the end of each treatment session with the primary comparison between the pre-first treatment session and the post-final treatment session. Total score range from 0-10, for both scales with a higher score indicating more pain.
次要结局
- Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.(immediately prior to and immediately following each session)
- Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions.(Prior to first therapy session and immediately after final therapy session)
- Change in number of medications used, daily morphine equivalents for opioids(Prior to first therapy session up to 1 week following last therapy session.)
- Change in total dose reduction for neuropathic pain(Prior to first therapy session up to 1 week following last therapy session.)
- Durability of pain relief as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.(1 month post therapy sessions, 6 months post therapy sessions)