A Randomized, Open, Comparative Clinical Investigation to Show the Efficacy of a Short Time, Whole Body, Electrostatic High Voltage Application for Relief of Chronic Pain. Included in Study Can be Persons Suffering From Chronic Pain as it is Often Case With Rheumatic Disease or Traumata
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).
研究概览
简要总结
The "Elosan Cabin" is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage in patients with chronic pain, especially those with rheumatic diseases. Patients assigned to the Elosan group (group A) will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions. Patients assigned to the control group (group B) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.
详细描述
Included in the study can be all persons suffering from chronic pain, as it is often the case with rheumatic disease or traumata. The Elosan therapy to be investigated aims to treat chronic pain by applying an electrical charge to the body surface and by disruption of positive bio-feedback to restore physiological reflex relations between the periphery and the central regulation. The electric charge is created by a generator which can produce an electrostatic field. The electrical voltage is delivered to the hands via a metal handle in a closed cabin and is spread over the entire body surface.
A total number of 42 patients will be included into this trial in order to show a statistically significant reduction of pain compared to reduction of pain in the control group.
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
- 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
- •Informed Consent
- •adults, age ≥ 18 years, male or female patients
- •History of pain ≥ 6 months
- •Suffering from chronic pain, either reumatic pain or pain caused by traumata
- •Intensity of pain rated ≥ 50 mm on VAS pain
排除标准
- •Untreated thyroid disease
- •History of seizure disorder (epilepsy)
- •History of or current psychosis
- •Women who are pregnant, breast feeding or intending to become pregnant
- •Patients who are currently participating in other studies or have participated in other studies within the last 30 days
- •Patients who have expressed their intention, or are suspected of intending, to discontinue therapy or stop therapy before the end of trial
- •Patients with an electric or electronic implant.
结局指标
主要结局
Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).
时间窗: Change from Baseline Intensity of pain at 4 weeks
Change of Pain Intensity is being assessed on a horizontal 100 mm VAS (Visual Analogue Scale) pain scale. The total range of this scale is 100 mm. Minimum score is 0 mm, Maximum score is 100 mm. The higher values represent a higher intensity of pain. The values at baseline will be compared to the values at Visit 8 and the mean of the differences will be compared between the 2 treatment arms.
次要结局
- Pain medication / pain therapy and any changes thereof shall be recorded during the study.(before and after 4 weeks of treatment)
- Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)(Change from Baseline at 4 weeks)