Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quantitative sensory testing (QST) | Procedure | with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 8 weeks after capsaicin-patch (8%) application |
| 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 | 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) | 8 weeks after capsaicin-patch (8%) application |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of thermal Hyperalgesia | change of thermal hyperalgesia measured by QST (z-value of heat pain and cold pain threshold)from baseline to 8 weeks after capsaicin-application | 8 weeks after capsaicin-patch (8%) application |
| Decrease of mechanical hyperalgesia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christoph Maier, Prof.Dr.med | University hospital Bergmannsheil department of pain management | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bergmannsheil, Department for pain management | Bochum | Germany |
Not provided
| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| D051474 | Neuralgia, Postherpetic |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 8 weeks after capsaicin-patch (8%) application |
| Decrease of dynamical mechanical allodynia | change of dynamical mechanical allodynia measured by QST from baseline to 8 weeks after capsaicin-application | 8 weeks after capsaicin-patch (8%) application |
| Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application | 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 | 8 weeks after application of capsaicin-patch (8%) |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |