A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics

February 28, 2012 updated by: Christoph Maier, Ruhr University of Bochum
Main of the present study was to develop a model of concomitant C-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (LA) to examine the sensory alterations after combined C-fiber block and sensitization in both different application orders (sensitization of blocked C-fibers and block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect stronger sensory changes during the combined substance application than during the monoapplication. We expect also contralateral sensory alterations mirroring the changes on the intervention site after the combined capsaicin and LA application, being stronger than after sensitization alone absent after C-fiber block alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

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

  • Germany
      • Bochum, Germany
        • Department of Pain Medicine

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subject, older than 18 years, provided written informed consent

Exclusion Criteria:

  • insufficient comprehension of the German language, history of severe internal, neurological or dermatological diseases, substance abuse, manifest psychiatric diseases, chronic and acute pain, any medication intake (except contraceptives in females) regularly or on demand during the last 14 days before study inclusion and during the study period, hypersensitivity to lidocaine or other amide-type anesthetics, hereditary or acquired methemoglobinemia, pregnancy, nursing, abnormal sensory profile in the quantitative sensory testing (QST) with side-to-side differences beyond the normal range at baseline and participation in clinical trials during the last month.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capsaicin application
application of 0.6%
Procedure: Application of capsaicin 0.6%
topical application of 0.6% capsaicin on the volar forearm
Experimental: Local anesthetics application
application of EMLA
Procedure: Application of local anesthetics (EMLA plaster)
topical application of EMLA on the volar forearm
Experimental: Combined application of 1. capsaicin 2. local anesthetics
application of 1. capsaicin 0.6% and 2. EMLA
Procedure: Application of 1 capsaicin 0.6% and 2. EMLA
topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm
Experimental: Combined application of 1. local anesthetics and 2. capsaicin
application of 1. EMLA and 2. capsaicin 0.6%
Procedure: Application of 1. EMLA and 2. capsaicin 0.6%
topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
grade of the ipsi- and contralateral hypoesthesia
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
area of the ipsi- and contralateral hypoesthesia
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Ruhr University of Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

February 29, 2012

Study Record Updates

Last Update Posted (Estimate)

February 29, 2012

Last Update Submitted That Met QC Criteria

February 28, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HypCap

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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