Cayenne Pepper Cataplasm - Effect Study

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705209
• Other study ID #: Munari02
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: March 4, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Cayenne Pepper Cataplasm
Poultice of Kaolin, Cayenne Peppfer (5%) and Water
• Placebo Cataplasm
Poultice of Kaolin and Water

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation	Vienna
Slovakia	Facultiy of Physical Education and Sports, Comenius University of Bratislava	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation	Comenius University

Countries where clinical trial is conducted

Austria,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Skin Temperature	measured via Infrared thermometer	before 1st and 3 weeks later after 10th intervention	No
Secondary	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	Yes
Secondary	Range of Motion (thoracic and lumbar spine)	Measured according to Schober and Ott test	before 1st and 3 weeks later after 10th intervention	No