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Study of Possible Changes in QST After Application of Capsaicin on Patients With Peripheral Neuropathic Pain

Information source: Ruhr University of Bochum
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peripheral Nerve Injury; Postherpetic Neuralgia

Intervention: quantitative sensory testing (QST) (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Ruhr University of Bochum

Official(s) and/or principal investigator(s):
Christoph Maier, Prof.Dr.med, Study Director, Affiliation: University hospital Bergmannsheil department of pain management

Summary

The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use of capsaicin on skin. 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.

Clinical Details

Official title: Kind and Duration of Possible Changes of the Sensory Profiles After the Topical Application of Capsaicin (8%) in Patients With Peripheral Neuropathic Pain

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Duration of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds

Extent of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds

Secondary outcome:

Decrease of thermal Hyperalgesia

Decrease of mechanical hyperalgesia

Decrease of dynamical mechanical allodynia

Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application

Detailed description: The topical application of a high dosage of capsaicin (8%) is a new promising approach. There is only little knowledge about the extent and the duration of drug-induced changes of detection and pain thresholds based on a currently recommended standardized quantitative sensory testing (QST). The assessment of QST changes would be an important step forward to understand the way of action as well as the time course of the presumed recovering of the C-fiber function after topical application of a high concentration capsaicin patch. 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age >18 years with signed informed consent

- 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 missing informed consent

- 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

Locations and Contacts

Bergmannsheil, Department for pain management, Bochum, Germany
Additional Information

Starting date: April 2011
Last updated: December 19, 2012

Page last updated: August 20, 2015

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