Study of Possible Changes in QST After Application of Capsaicin on Patients With Peripheral Neuropathic Pain
NCT ID: NCT01596491
Last Updated: 2012-12-20
Study Results
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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COMPLETED
20 participants
OBSERVATIONAL
2011-04-30
2012-11-30
Brief Summary
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The investigators first experiences with capsaicin in patients with peripheral nerve injury showed changes in the sensibility, which achieved its maximal extent after four weeks and was regressive, but not completely abolished 1,5 months after application.
In this study the investigators hope to specify, how long and in which way exactly this changes in sensibility appear.
Detailed Description
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10 patients suffering from peripheral neuropathic pain due to peripheral nerve injury and 10 patients suffering from postherpetic neuralgia will be investigated by QST following the protocol of DFNS (German Research Network on Neuropathic Pain), using both thermal and mechanical nociceptive as well as non-nociceptive stimuli.
QST will be performed at the following times:
* at baseline
* 2, 4, 6, 8 weeks later, and every two weeks at least until re-occurrence of pain and/or recovering of the capsaicin-induced worsening of the C-fiber function.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with peripheral nerve injury
10 patients with neuropathic pain, because of peripheral nerve injury will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits
quantitative sensory testing (QST)
with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified
patients with postherpetic neuralgia
10 patients with neuropathic pain, because of postherpetic neuralgia will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits
quantitative sensory testing (QST)
with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified
Interventions
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quantitative sensory testing (QST)
with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified
Eligibility Criteria
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Inclusion Criteria
* with planned topical application of capsaicin (8%) and with no involvement in any other study
* with neurological proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia) and with remaining moderate pain intensity under the current treatment (\> NRS 3; numeric rating scale 0-10)
* some remaining sensory function at the baseline QST with z-scores ≥ - 3 for cold, warmth and tactile thresholds
Exclusion Criteria
* with any contraindications for capsaicin application
* with diabetes mellitus,
* using lidocaine patch in the test area in the last 6 months before enrollment
* with inadequate knowledge of the german language
18 Years
ALL
No
Sponsors
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Ruhr University of Bochum
OTHER
Responsible Party
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Christoph Maier, Prof. Dr.
Head of the Dep. of Pain Management
Principal Investigators
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Christoph Maier, Prof.Dr.med
Role: STUDY_DIRECTOR
University hospital Bergmannsheil department of pain management
Locations
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Bergmannsheil, Department for pain management
Bochum, , Germany
Countries
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Other Identifiers
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Capsaicin2011
Identifier Type: -
Identifier Source: org_study_id