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

NCT ID: NCT01540877

Last Updated: 2012-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ipsi- and Contralateral Hypoesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Capsaicin application

application of 0.6%

Group Type EXPERIMENTAL

Application of capsaicin 0.6%

Intervention Type PROCEDURE

topical application of 0.6% capsaicin on the volar forearm

Local anesthetics application

application of EMLA

Group Type EXPERIMENTAL

Application of local anesthetics (EMLA plaster)

Intervention Type PROCEDURE

topical application of EMLA on the volar forearm

Combined application of 1. capsaicin 2. local anesthetics

application of 1. capsaicin 0.6% and 2. EMLA

Group Type EXPERIMENTAL

Application of 1 capsaicin 0.6% and 2. EMLA

Intervention Type PROCEDURE

topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm

Combined application of 1. local anesthetics and 2. capsaicin

application of 1. EMLA and 2. capsaicin 0.6%

Group Type EXPERIMENTAL

Application of 1. EMLA and 2. capsaicin 0.6%

Intervention Type PROCEDURE

topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm

Interventions

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Application of capsaicin 0.6%

topical application of 0.6% capsaicin on the volar forearm

Intervention Type PROCEDURE

Application of local anesthetics (EMLA plaster)

topical application of EMLA on the volar forearm

Intervention Type PROCEDURE

Application of 1 capsaicin 0.6% and 2. EMLA

topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm

Intervention Type PROCEDURE

Application of 1. EMLA and 2. capsaicin 0.6%

topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Christoph Maier

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pain Medicine

Bochum, , Germany

Site Status

Countries

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Germany

References

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Enax-Krumova EK, Pohl S, Westermann A, Maier C. Ipsilateral and contralateral sensory changes in healthy subjects after experimentally induced concomitant sensitization and hypoesthesia. BMC Neurol. 2017 Mar 23;17(1):60. doi: 10.1186/s12883-017-0839-9.

Reference Type DERIVED
PMID: 28335745 (View on PubMed)

Other Identifiers

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HypCap

Identifier Type: -

Identifier Source: org_study_id