Effect of Scramble Therapy on Chemotherapy Induced Peripheral Neuropathic Pain: A Prospective, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Chemotherapy induced peripheral neuropathic pain (CIPN) score difference
研究概览
简要总结
This trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. Scrambler therapy is a type of treatment that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of MC5-A scrambler therapy (scrambler therapy [ST]) in reducing chemotherapy-induced painful peripheral neuropathy (CIPPN).
II. Evaluate the change in pain score before and after 2 weeks (Monday-Friday) of the final ST treatment.
III. Assess for changes in other symptom burden (i.e insomnia, feeling of well-being, depression and anxiety) after 2 weeks (Monday-Friday) ST treatment.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of cancer and suffer from CIPN for at least 3 months after the end of their last cancer chemotherapy
- •Have average pain intensity of at least 4/10
- •Be in stable clinical situation (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled) in the month following the enrollment)
- •Can give a written informed consent
排除标准
- •Pre-existence or history of seizure
- •Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy (i.e. idiopathic peripheral neuropathy, diabetic neuropathy
- •Pregnancy
- •Present with pacemaker or implantable defibrillators
- •Present or past psychotropic substances and alcohol dependence
- •Inability to understand patients' information and informed consent
- •Skin lesion at the electrode placement site
结局指标
主要结局
Chemotherapy induced peripheral neuropathic pain (CIPN) score difference
时间窗: Baseline to the last day of 2-week treatment
Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
次要结局
- Change in therapy-induced neuropathy(Baseline to the last day of 2-week treatment)
- Change in cancer-related symptoms(Baseline to the last day of 2-week treatment)
- Change in physical function and quality of life(Baseline to the last day of 2-week treatment)