Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Annecy Genevois

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

"Neuropathic Pain 4" score ("DN4" score) ≥ 4/10

AND pain according to the numerical scale (EN) > 4/10,

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Patients with peripheral neuropathic pain and having an indication of capsaicin patches1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
12 months

Secondary outcomes

1

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)

Time frame
1.5 months after each consecutive patch
2

Proportion [95% CI] of patients "initial responder" at 50%

Time frame
12 months
3

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).

Time frame
Each 3 months and over 12 months
4

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

Time frame
Each 3 months and over 12 months

Other outcomes

Sponsors and contacts

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