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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Completed

CT.gov ID

NCT01596491

Collaborator

(none)

Enrollment

Location

19.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nerve Injury Postherpetic Neuralgia	Procedure: quantitative sensory testing (QST)

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.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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	Procedure: 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	Procedure: 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

Arm

Intervention/Treatment

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

Procedure: 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

Procedure: 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

Outcome Measures

Primary Outcome Measures

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 [8 weeks after capsaicin-patch (8%) application]
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)
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 [8 weeks after capsaicin-patch (8%) application]
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)

Secondary Outcome Measures

Decrease of thermal Hyperalgesia [8 weeks after capsaicin-patch (8%) application]
change of thermal hyperalgesia measured by QST (z-value of heat pain and cold pain threshold)from baseline to 8 weeks after capsaicin-application
Decrease of mechanical hyperalgesia [8 weeks after capsaicin-patch (8%) application]
change of mechanical hyperalgesia measured by QST (z-value of mechanical pain threshold and mechanical pain sensitivity) from baseline to 8 weeks after capsaicin-application
Decrease of dynamical mechanical allodynia [8 weeks after capsaicin-patch (8%) application]
change of dynamical mechanical allodynia measured by QST from baseline to 8 weeks after capsaicin-application
Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application [8 weeks after application of capsaicin-patch (8%)]
comparison of z-values for cold, warmth and mechanical detection threshold to the outcome of the german versions of the following questionnaires: PainDETECT, NPSI (Neuropathic Pain Symptom Inventory) and Patient's global impression of change (PGIC), analyzed by ANCOVA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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