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Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with peripheral neuropathic pain and having an indication of capsaicin patches | All patients will receive as part of routine care:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | In current practice, capsaicin patch treatment is offered to patients with a 24-hour average pain level measured by the EN numerical scale : EN scale is > 4 Pain monitoring questionnaires will be completed by patients every 6 weeks : Neuropathic Pain Symptom Invetory (NPSI Score), Patients' Global Impression of Change (PGIC scale), Numerical pain scale |
| Measure | Description | Time Frame |
|---|---|---|
| Factors (profiles) associated with a better initial response to pain desensitization by capsaicin | A patient is a responder if he has a reduction in pain, as measured by a numerical pain scale, of at least 30% from baseline. The scale used is "EN - échelle numérique" in french, "NRS - Numerical Rating Scale" in english, between 0 and 10 (0 being the absence of pain and 10 the most intense pain). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion [95% Confidence Interval (CI)] of patients "responder at 30%" at 1.5 months after each consecutive patch (e.g. at M4.5 for a second patch applied at M3) | 1.5 months after each consecutive patch | |
| Proportion [95% CI] of patients "initial responder" at 50% |
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Inclusion Criteria:
Patient over 18 years of age on the day of inclusion
Patient who has been informed and has not expressed opposition to participating in the study,
Patient with peripheral neuropathic pain (whatever the etiology), defined by :
Patient responding to an indication of desensitization to high concentration capsaicin concentration and not presenting any contra-indication.
Patient naïve of high concentration of Capsaicin on the concerned zone
Patient understanding French
Non-inclusion Criteria:
Exclusion Criteria:
None
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Eligible patients are identified during consultations for the treatment of their pain, carried out in the Chronic Pain Structures of the Auvergne Rhône-Alpes region. These patients must present peripheral neuropathic pain, whatever the etiology, and validated by a DN4 score ≥ 4/10 and a pain scale > 4/10, with a stable analgesic treatment for at least one month and for whom the investigator proposes a desensitization to high concentration Capsaicin.
Inclusion of consecutive patients in a consultation/day hospitalization setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion GHIDI | Contact | +33450637031 | drci.promotion@ch-annecygenevois.fr |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane FERRANDO, Doctor | Centre Hospitalier Annecy Genevois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Annecy Genevois | Recruiting | Annecy | 74370 | France |
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| 12 months |
| Distribution of Neuropathic Pain Symptom Inventory (NPSI) score values over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up | The NPSI scale is composed of 12 questions (10 descriptive questions of symptoms and 2 to evaluate the frequency and duration of pain). The score for the descriptive questions is between 0 and 100 (0 being the absence of pain and 10 the most intense pain). | Each 3 months and over 12 months |
| Distribution of NPSI subscores values (Q8, Q9, Q10) over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up | Each 3 months and over 12 months |
| Distribution of Patients' Global Impression of Change (PGIC) scale score values over time: at 1.5 months, 3 months, 4.5 months, 6 months, 7.5 months, 9 months,10.5 months, 12 months, and between inclusion and the end of follow-up | The Patients' Global Impression of Change (PGIC) scale describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life. It is between 1 and 7 (1 being no change or conditions has got worse, and 7 is a great deal better and a considerable improvement that as made all the difference). | Each 1.5 months and over 12 months |
| In the subpopulation of patients with allodynia (dynamic mechanical or static or thermal): proportion [95% CI] of "responders" at 7.5 months | 7.5 months |
| In the subpopulation of initial responders at the 30% threshold: proportion [95% CI] of patients relapsing at 12 months, defined as pain scale (EN) > 4/10, indicating a new capsaicin patch | 12 months |
| Number of new initiation of analgesic treatment, defined by the addition of a molecule to the treatment given at the time of application of the first capsaicin patch | 12 months |
| Number of reduction of analgesic treatment, defined by the stop of a molecule compared to the treatment given at the time of the application of the first capsaicin patch | 12 months |
| Hospices Civils de Lyon, Hôpital Pierre Wertheimer | Not yet recruiting | Bron | 69500 | France |
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| Centre Hospitalier Métropole Savoie | Recruiting | Chambéry | 73000 | France |
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| Centre Hospitalier Universitaire de Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Centre Hospitalier Universitaire Grenoble-Alpes | Recruiting | Grenoble | 38043 | France |
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| Hospices Civils de Lyon, Hôpital de la Croix Rousse | Not yet recruiting | Lyon | 69317 | France |
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| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
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| Centre Hospitalier Universitaire de Saint-Etienne | Not yet recruiting | Saint-Etienne | 42055 | France |
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| Clinique Mutualiste Chirurgicale de Saint Etienne | Recruiting | Saint-Etienne | 42100 | France |
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| Médipôle Lyon Villeurbanne | Not yet recruiting | Villeurbanne | 69100 | France |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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