Cayenne Pepper Cataplasm - Effect Study

NCT ID: NCT02705209

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-02-29

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.

Detailed Description

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Conditions

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Back Pain Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment

Group Type ACTIVE_COMPARATOR

Cayenne Pepper Cataplasm

Intervention Type OTHER

Poultice of Kaolin, Cayenne Peppfer (5%) and Water

Control

Group Type PLACEBO_COMPARATOR

Placebo Cataplasm

Intervention Type OTHER

Poultice of Kaolin and Water

Interventions

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Cayenne Pepper Cataplasm

Poultice of Kaolin, Cayenne Peppfer (5%) and Water

Intervention Type OTHER

Placebo Cataplasm

Poultice of Kaolin and Water

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Comenius University

OTHER

Sponsor Role collaborator

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

OTHER

Sponsor Role lead

Responsible Party

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Helmut Kern, MD PhD

Univ.-Prof. DDr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Vienna, , Austria

Site Status

Facultiy of Physical Education and Sports, Comenius University of Bratislava

Bratislava, , Slovakia

Site Status

Countries

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Austria Slovakia

Other Identifiers

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Munari02

Identifier Type: -

Identifier Source: org_study_id

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