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

December 20, 2023 updated by: Centre Hospitalier Annecy Genevois
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Annecy, France, 74370
      • Bron, France, 69500
        • Not yet recruiting
        • Hospices Civils de Lyon, Hôpital Pierre Wertheimer
        • Contact:
      • Chambéry, France, 73000
      • Clermont-Ferrand, France, 63000
      • Grenoble, France, 38043
        • Recruiting
        • Centre Hospitalier Universitaire Grenoble-Alpes
        • Contact:
      • Lyon, France, 69373
      • Lyon, France, 69317
        • Not yet recruiting
        • Hospices Civils de Lyon, Hôpital de la Croix Rousse
        • Contact:
      • Saint-Étienne, France, 42055
      • Saint-Étienne, France, 42100
      • Villeurbanne, France, 69100
        • Not yet recruiting
        • Médipôle Lyon Villeurbanne
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

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 :

    • "Neuropathic Pain 4" score ("DN4" score) ≥ 4/10
    • AND pain according to the numerical scale (EN) > 4/10,
    • AND stable analgesic treatment for at least 1 month,
    • AND with or without mechanical allodynia according to the Quantitative Sensory Testing (QST) : Brush test (dynamic), Von Frey test (static)
    • 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).
  • 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:

  • Patient with pain related to complex regional pain syndrome (criteria not meeting the indication for capsaicin)
  • Patient with active cancer (underlying disease and treatments may modify pain perception),
  • 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),
  • Patient with planned surgery within the next 12 months on the painful site (surgery may cause neuropathic damage and/or bias the pain assessment),
  • Patient included in an interventional research protocol,
  • Patient under guardianship or curators,
  • Patient under legal protection

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Questionnaires
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors (profiles) associated with a better initial response to pain desensitization by capsaicin
Time Frame: 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).
12 months

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: 1.5 months after each consecutive patch
1.5 months after each consecutive patch
Proportion [95% CI] of patients "initial responder" at 50%
Time Frame: 12 months
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
Time Frame: Each 3 months and over 12 months
Each 3 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
Time Frame: 7.5 months
7.5 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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 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).
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
Time Frame: 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).
Each 1.5 months and over 12 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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Annecy Genevois

Investigators

  • Principal Investigator: Stéphane FERRANDO, Doctor, Centre Hospitalier Annecy Genevois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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