Prospective, Multi-center, Clinical Trial (Phase IV Study) to Monitor the Efficacy of Treatment by Applying a High Electrostatic Charge to Patients With Chronic Pain, in the Practice of Clinical or Out-patient Pain Treatment Facilities.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 8
- 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 Treatment Cabin 'Elosan cabin' is a closed, electrically insulated cabin for the short-term application of a high electrostatic voltage to the body of patients with chronic pain.
Patients assigned will have 8 sessions in the treatment cabin, with an interval of 6 days between sessions. The existing therapies and painkillers will be continued at the discretion of the doctor.
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 electric charge is created by a generator which can produce a high electrostatic field. The electrical voltage is delivered to the hands via a metal handle and is spread over the entire body surface. After the short treatment, the patient is completely discharged and earthed again.
Over 100 patients in eight pain centers are to be included into this trial in order to show a statistically significant reduction of pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥ 3 months
- •Suffering from chronic pain
- •Intensity of pain rated ≥ 50 mm on VAS pain
排除标准
- •Patients with an electrical or electronic implant.
- •Women who are pregnant, breastfeeding or planning to become pregnant
- •Patients who have already been treated with the cabin within the last 4 weeks.
- •Patients who are currently participating in other studies or who have participated in other studies in the last 30 days
- •Patients who have indicated their intention or who are suspected of intending to discontinue or discontinue therapy before the end of the study
结局指标
主要结局
Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS)
时间窗: 8-9 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
- Composite outcome physical health (PCS) and mental health (MCS) to determine the quality of life assessed by the SF-12 Questionnaire(8-9 weeks)
- Pain medication / therapy and any changes thereof shall be recorded during the study.(8-9 weeks)