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Cayenne Pepper Cataplasm - Effect Study

Primary Purpose

Back Pain, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cayenne Pepper Cataplasm
Placebo Cataplasm
Sponsored by
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
  • Facultiy of Physical Education and Sports, Comenius University of Bratislava

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Skin Temperature
measured via Infrared thermometer
Blood Sample
test: hemogram, CRP, CK, blood sedimentation rate, albumin and different molecular markers
Range of Motion (thoracic and lumbar spine)
Measured according to Schober and Ott test

Full Information

First Posted
October 23, 2015
Last Updated
March 4, 2016
Sponsor
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Collaborators
Comenius University
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1. Study Identification

Unique Protocol Identification Number
NCT02705209
Brief Title
Cayenne Pepper Cataplasm - Effect Study
Official Title
Cayenne Pepper Cataplasm - Effect Study on Healthy Subjects and Subjects With Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Collaborators
Comenius University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Cayenne Pepper Cataplasm
Intervention Description
Poultice of Kaolin, Cayenne Peppfer (5%) and Water
Intervention Type
Other
Intervention Name(s)
Placebo Cataplasm
Intervention Description
Poultice of Kaolin and Water
Primary Outcome Measure Information:
Title
Two-point discrimination test
Description
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.
Time Frame
before 1st and 3 weeks later after 10th intervention
Secondary Outcome Measure Information:
Title
Monofilament Test
Description
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.
Time Frame
before 1st and 3 weeks later after 10th intervention
Title
Skin Temperature
Description
measured via Infrared thermometer
Time Frame
before 1st and 3 weeks later after 10th intervention
Title
Blood Sample
Description
test: hemogram, CRP, CK, blood sedimentation rate, albumin and different molecular markers
Time Frame
before, 1h and 48h after the first intervention and 3 weeks later before, 1h and 48h after 10 interventions
Title
Range of Motion (thoracic and lumbar spine)
Description
Measured according to Schober and Ott test
Time Frame
before 1st and 3 weeks later after 10th intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Facultiy of Physical Education and Sports, Comenius University of Bratislava
City
Bratislava
ZIP/Postal Code
81806
Country
Slovakia

12. IPD Sharing Statement

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Cayenne Pepper Cataplasm - Effect Study

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