Scrambler Therapy for the Treatment of Chronic Zoster Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in pain on a 0-10 numerical rating scale.
研究概览
简要总结
This pilot clinical trial studies how well scrambler therapy works treating chronic pain in patients with rash from varicella zoster virus infection. Scrambler therapy may help relieve pain from a rash caused by varicella zoster virus infection
详细描述
PRIMARY OBJECTIVES:
I. To explore whether we can decrease post-herpetic neuralgia (PHN) pain with scrambler therapy.
OUTLINE: Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity. After the completion of study treatment, patients are followed up for 10 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain of >= 1 month (30 days) duration attributed to zoster, for which the patient wants intervention
- •Pain at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
- •Life expectancy >= 3 months (90 days)
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed written consent
排除标准
- •Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
- •Pregnant women
- •Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
- •Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices)
- •Patients with a history of myocardial infarction or ischemic heart disease within the past six months
- •Patients with history of epilepsy, brain damage, use of anti-convulsants for seizure prevention, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
- •Other identified causes of pain in the area that was affected by herpes zoster
- •Skin conditions such as open sores that would prevent proper application of the electrodes
- •Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
- •Prior treatment with Calmare MC-5A therapy
- •Patient initiation of a new analgesic treatment within 7 days prior to initiation of protocol treatment
研究组 & 干预措施
Treatment (pain therapy)
Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity.
干预措施: scrambler therapy (Other)
Treatment (pain therapy)
Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Treatment (pain therapy)
Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity.
干预措施: dermatologic complications management/prevention (Procedure)
结局指标
主要结局
Change in pain on a 0-10 numerical rating scale.
时间窗: 10 weeks
次要结局
未报告次要终点