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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001540-22 | EudraCT Number |
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Expiration of the placebo patch
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In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capsaicin patch | Active Comparator |
| |
| placebo patch | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsaicin patch (qutenza) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pain change capsaicin vs. placebo patch treatment | Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days at baseline and at 1 months, 2 months and 3 months during follow-up. The primary outcome measure is the maximum difference between the summed pain intensity differences (SPID) for the phases: Baseline, 1 month, 2 month or 3 month. Δ SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients. | Pain intensity assessed at baseline and at 1,2,3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in AAS (Activities Assessment Scale) score | ||
| Changes in HADS (Hospital Anxiety and Depression Scale) score | ||
| Changes in QST (Quantitative sensory testing) |
| Measure | Description | Time Frame |
|---|---|---|
| interim analyses | An interim analysis evaluating pain change (SPID) for capsaicin patch vs. placebo treatment by an independent statistician following completion of 32 patients. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Copenhagen Ø | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25290151 | Derived | Bischoff JM, Ringsted TK, Petersen M, Sommer C, Uceyler N, Werner MU. A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial. PLoS One. 2014 Oct 7;9(10):e109144. doi: 10.1371/journal.pone.0109144. eCollection 2014. |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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|
| Changes in sleep (Sleep Interference Scale) score |
| Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs) |
| Changes in intraepidermal nerve fiber density |
| Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia |
| Changes in PCS (Pain Catastrophizing Scale) score |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |