Clinical trial NCT01596491: Study of Possible Changes in QST After Application of Capsaicin on Patients With Peripheral Neuropathic Pain
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nerve Injury
Postherpetic Neuralgia
Keywords: peripheral nerve injury
postherpetic neuralgia
PNI
PHN
Capsaicin
QST
quantitative sensory testing
sensory profile
neuropathic pain
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia)

Brief 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.

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 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

Primary outcomes:
measure: 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
timeFrame: 8 weeks after capsaicin-patch (8%) application
measure: 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
timeFrame: 8 weeks after capsaicin-patch (8%) application
Secondary outcomes:
measure: Decrease of thermal Hyperalgesia
timeFrame: 8 weeks after capsaicin-patch (8%) application
measure: Decrease of mechanical hyperalgesia
timeFrame: 8 weeks after capsaicin-patch (8%) application
measure: Decrease of dynamical mechanical allodynia
timeFrame: 8 weeks after capsaicin-patch (8%) application
measure: Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application
timeFrame: 8 weeks after application of capsaicin-patch (8%)
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Bergmannsheil, Department for pain management
Study officials:
affiliation: University hospital Bergmannsheil department of pain management
name: Christoph Maier, Prof.Dr.med
role: STUDY_DIRECTOR
References: