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Cayenne Pepper Cataplasm - Safety Study

NCT03440125 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-20

No results posted yet for this study

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. However, a concern about the safety of such applications was recently raised.

Therefore, the aims of the present study are to evaluate the effects of 10x 20min CP cataplasm application as a single treatment or in combination with electrical stimulation and massage on selected functional and molecular parameters on i) healthy subjects and ii) subjects suffering from low back pain.

Conditions

  • Low Back Pain

Interventions

DRUG

Cayenne Pepper topical

20min topical Cayenne Pepper Cataplasm application containing 5% Cayenne Pepper nd 95% Kaolin mixed with water

DEVICE

Electrical stimulation

Electrical stimulation 10min 60Hz biphasic rectangular neuromuscular electrical Stimulation (NMES)

PROCEDURE

Massage

10 minutes of classical massage of low back pain area.

Sponsors & Collaborators

  • S2P, Science to Practice, Ltd.

    collaborator OTHER

  • Comenius University

    collaborator OTHER

  • Wilhelminenspital Vienna

    collaborator OTHER

  • Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

    collaborator OTHER

  • University of Primorska

    lead OTHER

Principal Investigators

  • Nejc Šarabon, PhD · Faculty of Health Sciences, University of Primorska, Slovenia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-15
Primary Completion
2016-11-15
Completion
2016-12-15

Countries

  • Slovakia
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440125 on ClinicalTrials.gov