Cayenne Pepper Cataplasm - Safety Study (Munari04)

February 19, 2018 updated by: Nejc Sarabon, University of Primorska

Cayenne Pepper Cataplasm Application and Potential Side Effects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Musculoskeletal diseases, such as neck and low back pain, are widespread disorders in many developed countries. Their management is challenging, and it may have mounting socioeconomic burden. Several evidences in the literature demonstrate the efficacy of many therapeutic strategies in the treatment of these conditions, based on pharmacological or surgical interventions. Physical medicine therapies are good alternatives that may have beneficial effects, especially when used as first line of intervention before approaching more expensive pharmacological or invasive medications. The beneficial analgesic effects of Applicatio Epispasticorum 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 (CP), are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. They are also used in pain involving joints caused by osteoarthritis. A galenic preparation composed of rubefacient substances of vegetable origin, which generated vasodilation and increase in blood circulation on the treated areas, was first prescribed in 1909 by Dr. Giuseppe Munari to treat pain of various areas of the locomotive system. He proposed a method based on applications prepared according to his own galenic formula that have become famous all over Italy and Europe. In Vienna and lower Austria, a Munari-like application containing CP and Kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back. The research on responses to CPC applications, particularly in combination with other modalities is scarce.

Therefore, the aims of the present study are firstly to evaluate the effects of 10x 20min CP cataplasm application on selected functional and molecular parameters on healthy subjects. Then, the same applications will be used on subjects suffering from low back pain (LBP) - both as a single treatment and in combination with electrical stimulation and massage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 81806
        • Facultiy of Physical Education and Sports, Comenius University of Bratislava
  • Slovenia
      • Izola, Slovenia, 6310
        • Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic low back pain (>3 months)
  • Body mass index below 35 kg/mˇ2

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy
Healthy participants with no low back pain. 20 min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical) on the back will be administered.
Drug: Cayenne Pepper topical
20min topical Cayenne Pepper Cataplasm application containing 5% Cayenne Pepper nd 95% Kaolin mixed with water
Other Names:
  • Cayenne Pepper Cataplasm application
Experimental: LBP patients - CPC Group
Participants suffering from low back pain (LBP) receiving 10 times (within 3 weeks) 20min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical).
Drug: Cayenne Pepper topical
20min topical Cayenne Pepper Cataplasm application containing 5% Cayenne Pepper nd 95% Kaolin mixed with water
Other Names:
  • Cayenne Pepper Cataplasm application
Experimental: LBP patients - CPC and ES/M Group
Participants suffering from low back pain (LBP) receiving 10 times (within 3 weeks) 20min application of Cayenne Pepper Cataplasm (Cayenne Pepper topical), and half of the subject also receiving 10 min electrical Stimulation and 10 min massage Treatment on the back.
Drug: Cayenne Pepper topical
20min topical Cayenne Pepper Cataplasm application containing 5% Cayenne Pepper nd 95% Kaolin mixed with water
Other Names:
  • Cayenne Pepper Cataplasm application
Device: Electrical stimulation
Electrical stimulation 10min 60Hz biphasic rectangular neuromuscular electrical Stimulation (NMES)
Other Names:
  • Neuromuscular Electrical Stimulation (NMES)
Procedure: Massage
10 minutes of classical massage of low back pain area.
Other Names:
  • Classical massage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in concentration of circulating biomarkers of inflammation, neudroendocrine stress and blood vessel activation
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
The blood analysis will include standard analysis of hemogram, C-reactive proteins, creatine-kinase, sedimentation, albumin and cortisol. Enzyme-linked immunosorbent assay (ELISA) will include Tumor necrosis factor-Alpha, Interleukin-6, Leukotriene B4 and P-Selectine. Additionally, microRNA analysis will be performed (gene numbers: 1, 21, 23, 25, 103, 126, 133, 146, 155, 199a, 199b, 191, 206, 451.
Before the application, 45 minutes after 10th application and 48 hours after 10th application
Change in systolic and diastolic blood pressure
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Systolic and diastolic blood pressure [mmHg], measured at both sides of the body with blood pressure gauge
Before the application, 45 minutes after 10th application and 48 hours after 10th application
Heart rate
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Heart rate (bpm), measured with heart rate monitor belt.
Before the application, 45 minutes after 10th application and 48 hours after 10th application

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
36-Item Short Form Survey (SF-36)
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
The Short Form (36) Health Survey (SF-36) is a patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums all questions in their respective section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the higher is the disability.
Before the application, 45 minutes after 10th application and 48 hours after 10th application
Change in pain perception
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Pain perception during rest and movement assessed with visual analogue scale (0-10). 0 represents no pain, and 10 represents severe pain.
Before the application, 45 minutes after 10th application and 48 hours after 10th application
EQ-5D- 5L questionnaire
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
EQ-5D- 5L questionnaire includes following aspects: mobility, care, usual activities, pain/discomfort, anxiety/depression, crosswalk-index, self-feeling of health. Each aspect is evaluated on a 1-5 scale, with following descriptions of levels: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Before the application, 45 minutes after 10th application and 48 hours after 10th application
Oswestry disability index (ODI)
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
ODI will be used only in LBP arms (Arm 2 and 3). ODI is commonly used by clinicians and researchers to quantify disability for low back pain.
Before the application, 45 minutes after 10th application and 48 hours after 10th application
Skin Sensory Function
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Skin sensory function will be assessed by 2-point discrimination test (which is carried out using two pins, oriented in medial-lateral direction and pressed perpendicularly to the skin, with the medial pin being 3 cm laterally from the L3 spinal process. The subject is asked to report whether he/she felt one or two pins) and mono filament/light touch sensitivity tests (monofilaments calibrated to 0.025, 0.07, 2, 5, and 10 grams The subject is asked to report when he/she felt touching the skin with a monofilament 3 cm laterally from L3 spinal process). The lightest mono filament and the lowest pin inter-distance are take as final outcome measures.
Before the application, 45 minutes after 10th application and 48 hours after 10th application
Flexibility
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Assessment of total spine flexibility (forward bend test) and separately for the lumbar part (Schober's test) and thoracic part.
Before the application, 45 minutes after 10th application and 48 hours after 10th application
Skin Temperature
Time Frame: Before the application, 45 minutes after 10th application and 48 hours after 10th application
Skin temperature [°C] at the site of application (low back) and at the control part of the body (neck), measured with a laser thermometer.
Before the application, 45 minutes after 10th application and 48 hours after 10th application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Primorska

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Comenius University
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
S2P, Science to Practice, Ltd.
Wilhelminenspital Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nejc Šarabon, PhD, Faculty of Health Sciences, University of Primorska, Slovenia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP-MunariStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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