Cayenne Pepper Cataplasm - Effect Study

Study Overview
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Brief Summary
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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.

Official Title
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Cayenne Pepper Cataplasm - Effect Study on Healthy Subjects and Subjects With Back Pain

Conditions
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Back Pain, Low Back Pain

Intervention / Treatment
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* Other: Cayenne Pepper Cataplasm
* Other: Placebo Cataplasm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic lumbar spine pain >= 3 months pain during activity VAS >= 4 Oswestry Disabilty Index >= 20% Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br> | Other: Cayenne Pepper Cataplasm<br>* Poultice of Kaolin, Cayenne Peppfer (5%) and Water<br>|
| Placebo Comparator: Control<br> | Other: Placebo Cataplasm<br>* Poultice of Kaolin and Water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-point discrimination test | 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. | before 1st and 3 weeks later after 10th intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monofilament Test | Different monofilaments (Semmes-Weinstein) will be randomly pressed perpendicular to the same area as primary outcome measure. The thinest filament recognized from the subject will be taken as the result of the test. | before 1st and 3 weeks later after 10th intervention | 
| Skin Temperature | measured via Infrared thermometer | before 1st and 3 weeks later after 10th intervention | 
| Blood Sample | test: hemogram, CRP, CK, blood sedimentation rate, albumin and different molecular markers | before, 1h and 48h after the first intervention and 3 weeks later before, 1h and 48h after 10 interventions | 
| Range of Motion (thoracic and lumbar spine) | Measured according to Schober and Ott test | before 1st and 3 weeks later after 10th intervention |