Cayenne Pepper Cataplasm - Effect Study

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Low Back Pain
• Intervention / Treatment: Other: Cayenne Pepper Cataplasm; Other: Placebo Cataplasm

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Placebo Cataplasm; Poultice of Kaolin and Water
Active Comparator: Treatment	Other: Cayenne Pepper Cataplasm; Poultice of Kaolin, Cayenne Peppfer (5%) and Water

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
• Collaborators: Comenius University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 4, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Munari02