NCT02705209

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

October 23, 2015

Last Update Submit

March 4, 2016

Conditions

Back PainLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Monofilament Test

    before 1st and 3 weeks later after 10th intervention

  • Skin Temperature

    before 1st and 3 weeks later after 10th intervention

  • Blood Sample

    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)

    before 1st and 3 weeks later after 10th intervention

Study Arms (2)

Treatment

ACTIVE COMPARATOR
Other: Cayenne Pepper Cataplasm

Control

PLACEBO COMPARATOR
Other: Placebo Cataplasm

Interventions

Cayenne Pepper CataplasmOTHER

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

Treatment
Placebo CataplasmOTHER

Poultice of Kaolin and Water

Control

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic lumbar spine pain \>= 3 months
  • pain during activity VAS \>= 4
  • Oswestry Disabilty Index \>= 20%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Vienna, 1160, Austria

Location

Facultiy of Physical Education and Sports, Comenius University of Bratislava

Bratislava, 81806, Slovakia

Location

MeSH Terms

Conditions

Back PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. DDr.

Study Record Dates

First Submitted

October 23, 2015

First Posted

March 10, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations

AU(1)SL(1)