Cayenne Pepper Cataplasm - Effect Study on Healthy Subjects and Subjects With Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Two-point discrimination test
研究概览
简要总结
The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since 1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC) application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back.
Therefore, the aim of the present study was to test effects of a series of ten applications of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature, skin sensory functions, pain threshold, and proprioception. Placebo control condition (0% cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application of a CPC will have significant effects on the measured parameters.
40 subjects will be randomized into Treatment/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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic lumbar spine pain >= 3 months
- •pain during activity VAS >= 4
- •Oswestry Disabilty Index >= 20%
排除标准
- •pregnancy
- •sensibility disorders (e.g. due to neurological disease)
- •injuries, open wounds or rash in intervention area
- •known hypersensitivity against the applied substances
- •HIV, Hepatitis C and other due blood communicable infectious diseases
结局指标
主要结局
Two-point discrimination test
时间窗: before 1st and 3 weeks later after 10th intervention
The subject is lying prone during the test and test will be performed with a BASELINE Aesthesiometer (0-100mm). The test will be performed at the level of L3 spinal process, the medial pin 3 cm laterally from midline and the pins oriented in medial-lateral direction. The two pins will be pressed perpendicular to the skin and the subject will be asked to report whether he/she feels one or two pins. Each inter-pin distance will be used three times using single pin touches in between for a control. The smallest inter-pin distance which the subject reports correctly at least 2 out of 3 repetitions, will be taken, as the result of the test.
次要结局
- Monofilament Test(before 1st and 3 weeks later after 10th intervention)
- Blood Sample(before, 1h and 48h after the first intervention and 3 weeks later before, 1h and 48h after 10 interventions)
- Skin Temperature(before 1st and 3 weeks later after 10th intervention)
- Range of Motion (thoracic and lumbar spine)(before 1st and 3 weeks later after 10th intervention)
研究者
Helmut Kern, MD PhD
Univ.-Prof. DDr.
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation