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Completed

NCT Number: NCT02705209

Cayenne Pepper Cataplasm - Effect Study

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.

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Key information

Conditions

Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cayenne Pepper Cataplasm

Other

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

Placebo Cataplasm

Other

Poultice of Kaolin and Water

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Other

Collaborators

  • Comenius University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 10, 2016
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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