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Trial record 1 of 1 for:    NCT01540877
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A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics

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ClinicalTrials.gov Identifier: NCT01540877
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : February 29, 2012
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum

Tracking Information
First Submitted Date  ICMJE February 23, 2012
First Posted Date  ICMJE February 29, 2012
Last Update Posted Date February 29, 2012
Study Start Date  ICMJE April 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2012)
grade of the ipsi- and contralateral hypoesthesia [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2012)
area of the ipsi- and contralateral hypoesthesia [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Ipsi- and Contralateral Hypoesthesia
Intervention  ICMJE
  • Procedure: Application of capsaicin 0.6%
    topical application of 0.6% capsaicin on the volar forearm
  • Procedure: Application of local anesthetics (EMLA plaster)
    topical application of EMLA on the volar forearm
  • Procedure: Application of 1 capsaicin 0.6% and 2. EMLA
    topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm
  • Procedure: Application of 1. EMLA and 2. capsaicin 0.6%
    topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm
Study Arms  ICMJE
  • Experimental: Capsaicin application
    application of 0.6%
    Intervention: Procedure: Application of capsaicin 0.6%
  • Experimental: Local anesthetics application
    application of EMLA
    Intervention: 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
    Intervention: 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%
    Intervention: Procedure: Application of 1. EMLA and 2. capsaicin 0.6%
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2012)
28
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01540877
Other Study ID Numbers  ICMJE HypCap
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christoph Maier, Ruhr University of Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ruhr University of Bochum
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP