CAPSICAURA: Response Profiles to High-concentration Capsaicin Desensitization in Patients With Peripheral Neuropathic Pain With or Without Allodynia: a Regional Multicenter Prospective Cohort
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients with peripheral neuropathic pain and having an indication of capsaicin patches All patients will receive as part of routine care: Three consecutive patches of 8% capsaicin in localized application for 30 to 60 minutes once every 3 months : at M0 (study inclusion), M3 and M6, or until pain scale < 4/10 (between 0 and 10), Pain assessment every 1.5 months (+/-7 days), to evaluate clinical response, 8% capsaicin patches if the pain assessment rises again to pain scale > 4/10, after an initial response to treatment |
Drug: Capsaicin 8%
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
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Outcome Measures
Primary Outcome Measures
- Factors (profiles) associated with a better initial response to pain desensitization by capsaicin [12 months]
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).
Secondary Outcome Measures
- 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% [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 [Each 3 months and over 12 months]
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).
- 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 [Each 1.5 months and over 12 months]
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).
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient over 18 years of age on the day of inclusion
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Patient who has been informed and has not expressed opposition to participating in the study,
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Patient with peripheral neuropathic pain (whatever the etiology), defined by :
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"Neuropathic Pain 4" score ("DN4" score) ≥ 4/10
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AND pain according to the numerical scale (EN) > 4/10,
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AND stable analgesic treatment for at least 1 month,
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AND with or without mechanical allodynia according to the Quantitative Sensory Testing (QST) : Brush test (dynamic), Von Frey test (static)
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AND with or without thermal allodynia to hot or cold as determined by a ROLLTEMP-II® (Rolltemp is a device designed for quick screening of temperature sensibility over large body areas).
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Patient responding to an indication of desensitization to high concentration capsaicin concentration and not presenting any contra-indication.
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Patient naïve of high concentration of Capsaicin on the concerned zone
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Patient understanding French
Non-inclusion Criteria:
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Patient with pain related to complex regional pain syndrome (criteria not meeting the indication for capsaicin)
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Patient with active cancer (underlying disease and treatments may modify pain perception),
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Patient receiving or having received in the last 3 months Botulinum toxin A on the concerned area (this treatment of neuropathic pain may modulate the effect of capsaicin and disturb the demonstration of causality),
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Patient with planned surgery within the next 12 months on the painful site (surgery may cause neuropathic damage and/or bias the pain assessment),
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Patient included in an interventional research protocol,
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Patient under guardianship or curators,
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Patient under legal protection
Exclusion Criteria:
None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Hospitalier Annecy Genevois
Investigators
- Principal Investigator: Stéphane FERRANDO, Doctor, Centre Hospitalier Annecy Genevois
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-50