Back to resultsA Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
Primary Purpose
Ipsi- and Contralateral Hypoesthesia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Application of capsaicin 0.6%
Application of local anesthetics (EMLA plaster)
Application of 1 capsaicin 0.6% and 2. EMLA
Application of 1. EMLA and 2. capsaicin 0.6%
Sponsored by
About this trial
This is an interventional basic science trial for Ipsi- and Contralateral Hypoesthesia
Eligibility Criteria
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.
Sites / Locations
- Department of Pain Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Capsaicin application
Local anesthetics application
Combined application of 1. capsaicin 2. local anesthetics
Combined application of 1. local anesthetics and 2. capsaicin
Arm Description
application of 0.6%
application of EMLA
application of 1. capsaicin 0.6% and 2. EMLA
application of 1. EMLA and 2. capsaicin 0.6%
Outcomes
Primary Outcome Measures
grade of the ipsi- and contralateral hypoesthesia
Secondary Outcome Measures
area of the ipsi- and contralateral hypoesthesia
Full Information
NCT ID
NCT01540877
First Posted
February 23, 2012
Last Updated
February 28, 2012
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT01540877
Brief Title
A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ipsi- and Contralateral Hypoesthesia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capsaicin application
Arm Type
Experimental
Arm Description
application of 0.6%
Arm Title
Local anesthetics application
Arm Type
Experimental
Arm Description
application of EMLA
Arm Title
Combined application of 1. capsaicin 2. local anesthetics
Arm Type
Experimental
Arm Description
application of 1. capsaicin 0.6% and 2. EMLA
Arm Title
Combined application of 1. local anesthetics and 2. capsaicin
Arm Type
Experimental
Arm Description
application of 1. EMLA and 2. capsaicin 0.6%
Intervention Type
Procedure
Intervention Name(s)
Application of capsaicin 0.6%
Intervention Description
topical application of 0.6% capsaicin on the volar forearm
Intervention Type
Procedure
Intervention Name(s)
Application of local anesthetics (EMLA plaster)
Intervention Description
topical application of EMLA on the volar forearm
Intervention Type
Procedure
Intervention Name(s)
Application of 1 capsaicin 0.6% and 2. EMLA
Intervention Description
topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm
Intervention Type
Procedure
Intervention Name(s)
Application of 1. EMLA and 2. capsaicin 0.6%
Intervention Description
topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm
Primary Outcome Measure Information:
Title
grade of the ipsi- and contralateral hypoesthesia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
area of the ipsi- and contralateral hypoesthesia
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Pain Medicine
City
Bochum
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28335745
Citation
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.
Results Reference
derived
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A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
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