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CompletedNCT01540877Updated Feb 29, 2012

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

An interventional study of Application of capsaicin 0.6% and Application of local anesthetics (EMLA plaster) in Ipsi- and Contralateral Hypoesthesia, sponsored by Ruhr University of Bochum. Completed at 1 site in Germany. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-29.

Sponsored by Ruhr University of Bochum · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ipsi- and Contralateral Hypoesthesia

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03

In context

Hypesthesia

47 studies on the registry are indexed under Hypesthesia; 12 are open to participants now.

This study's enrollment of 28 is below the median of 50 across 43 interventional studies indexed under Hypesthesia.

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Lead sponsor

Ruhr University of Bochum is the lead sponsor of 126 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy subject, older than 18 years, provided written

Exclusion criteria

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 in females) regularly or on demand during the last 14 days before study inclusion and during the study period, 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.
Terms in these criteria, in plain language(3)

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Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

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Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Capsaicin application

    application of 0.6%

    Procedure: Application of capsaicin 0.6%

  • Experimental
    Local anesthetics application

    application of EMLA

    Procedure: Application of local anesthetics (EMLA plaster)

  • 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

  • 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%

Interventions

  • ProcedureApplication of capsaicin 0.6%

    topical application of 0.6% capsaicin on the volar forearm

  • ProcedureApplication of local anesthetics (EMLA plaster)

    topical application of EMLA on the volar forearm

  • ProcedureApplication of 1 capsaicin 0.6% and 2. EMLA

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

  • ProcedureApplication of 1. EMLA and 2. capsaicin 0.6%

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

06

What researchers measure

Primary outcomes

  1. grade of the ipsi- and contralateral hypoesthesia

    Time frame: 6 months

Secondary outcomes

  1. area of the ipsi- and contralateral hypoesthesia

    Time frame: 6 months

07

Study locations

1 site
  • Department of Pain Medicine
    Bochum, Germany
08

References and documents

Publications

  • 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. PubMed 28335745 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2011 and a primary completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2012
First posted
Feb 29, 2012
Start
Apr 2011
Primary completionActual
Sep 2011
Last update
Feb 29, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01540877
Responsible party
Christoph Maier (Prof. Dr. med., Ruhr University of Bochum) — Principal investigator
First posted
Feb 29, 2012
Start date
Apr 2011
Primary completion
Sep 2011
Last update
Feb 29, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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