Peripheral Neuropathic PainCAPSICAURANCT05817591
Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
An observational study of Peripheral Neuropathic Pain, run by Centre Hospitalier Annecy Genevois at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathic Pain
- What is being tested?
- Questionnaires
- How many people
- 400 participants
- Where
- 10 sitesFrance
- Study dates
- 14 Dec 2023to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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,
Show all 19Show fewer
- 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
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Centre Hospitalier Annecy Genevois
Annecy, 74370
Stéphane FERRANDO, Doctor, sferrando@ch-annecygenevois.fr
- Not yet recruiting
Hospices Civils de Lyon, Hôpital Pierre Wertheimer
Bron, 69500
Christian GOV, Doctor, Christian.gov@chu-lyon.fr
- Recruiting
Centre Hospitalier Métropole Savoie
Chambéry, 73000
Valérie ROULLOT-PRADEL, Doctor, valerie.roullot.pradel@ch-metropole-savoie.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
Noémie DELAGE, Doctor, ndelage@chu-clermontferrand.fr
- Recruiting
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble, 38043
Caroline MAINDET, Doctor, cmaindet@chu-grenoble.fr
- Not yet recruiting
Hospices Civils de Lyon, Hôpital de la Croix Rousse
Lyon, 69317
Mikhail DZIADZKO, Doctor, mikhail.dziadzko@chu-lyon.fr
- Recruiting
Centre Léon Bérard
Lyon, 69373
Olivier RENARD, Doctor, olivier.renard@lyon.unicancer.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
Christelle CREAC'H, Doctor, christelle.creach@univ-st-etienne.fr
- Recruiting
Clinique Mutualiste Chirurgicale de Saint Etienne
Saint-Etienne, 42100
Denis BAYLOT, Doctor, Denis.BAYLOT@lyon.unicancer.fr
- Not yet recruiting
Médipôle Lyon Villeurbanne
Villeurbanne, 69100
Mario BARMAKI, Doctor, mariobarmaki@aol.com
About this study
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.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (9)
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)
Measured: 1.5 months after each consecutive patch
Proportion [95% CI] of patients "initial responder" at 50%
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start14 Dec 2023
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane FERRANDO, Doctor, Principal investigator, Centre Hospitalier Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817591
- Sponsor's protocol ID
- 19-50
- Acronym
- CAPSICAURA
- Status last verified
- Feb 2025
- First submitted
- 5 Apr 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort
- ClinicalTrials.gov ID
- NCT05817591
- Acronym / sponsor ID
- CAPSICAURA / 19-50
- Conditions
- Peripheral Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral neuropathic pain and having an indication of capsaicin patches | – | Other: QuestionnairesAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesIn 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 | Other | Patients with peripheral neuropathic pain and having an indication of capsaicin patches |
Primary outcome
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).
9 secondary outcomes
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
Proportion [95% CI] of patients "initial responder" at 50%
Time frame: 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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane FERRANDO, Doctor principal investigator
Centre Hospitalier Annecy Genevois
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathic Pain, run by Centre Hospitalier Annecy Genevois at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion GHIDI (+33450637031, drci.promotion@ch-annecygenevois.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors (profiles) associated with a better initial response to pain desensitization by capsaicin (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.