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NCT Number: NCT05817591

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

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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Key information

Conditions

Peripheral Neuropathic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Annecy Genevois, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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).

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

    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).

  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

  5. 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).

  6. 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. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marion GHIDI

CONTACT

[email protected]

+33450637031

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Annecy Genevois

Other

Registry information

Acronym: CAPSICAURA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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