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Cayenne Pepper Cataplasm - Effect Study

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ClinicalTrials.gov Identifier: NCT02705209
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
Comenius University
Information provided by (Responsible Party):
Helmut Kern, MD PhD, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

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.


Condition or disease Intervention/treatment Phase
Back Pain Low Back Pain Other: Cayenne Pepper Cataplasm Other: Placebo Cataplasm Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cayenne Pepper Cataplasm - Effect Study on Healthy Subjects and Subjects With Back Pain
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Treatment Other: Cayenne Pepper Cataplasm
Poultice of Kaolin, Cayenne Peppfer (5%) and Water

Placebo Comparator: Control Other: Placebo Cataplasm
Poultice of Kaolin and Water




Primary Outcome Measures :
  1. Two-point discrimination test [ Time Frame: 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.


Secondary Outcome Measures :
  1. Monofilament Test [ Time Frame: before 1st and 3 weeks later after 10th intervention ]
    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.

  2. Skin Temperature [ Time Frame: before 1st and 3 weeks later after 10th intervention ]
    measured via Infrared thermometer

  3. Blood Sample [ Time Frame: before, 1h and 48h after the first intervention and 3 weeks later before, 1h and 48h after 10 interventions ]
    test: hemogram, CRP, CK, blood sedimentation rate, albumin and different molecular markers

  4. Range of Motion (thoracic and lumbar spine) [ Time Frame: before 1st and 3 weeks later after 10th intervention ]
    Measured according to Schober and Ott test



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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705209


Locations
Austria
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Vienna, Austria, 1160
Slovakia
Facultiy of Physical Education and Sports, Comenius University of Bratislava
Bratislava, Slovakia, 81806
Sponsors and Collaborators
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Comenius University

Responsible Party: Helmut Kern, MD PhD, Univ.-Prof. DDr., Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
ClinicalTrials.gov Identifier: NCT02705209     History of Changes
Other Study ID Numbers: Munari02
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms