Neuropathic PainCAPSASENSNCT07660510
Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches
A study testing Quantitative Sensory Testing and questionnaires in people with Neuropathic Pain and Nociplastic Pain, run by Nantes University Hospital at 1 site in France.
Trial summary
The primary objective of this study will be to demonstrate a change in pain sensitization parameters before and after the application of the high-concentration capsaicin patch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Nociplastic Pain
- What is being tested?
- Quantitative Sensory Testing and questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Interventional
- 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
Who may be able to join
- Men or women ≥ 18 years old.
- Patients suffering from chronic pelvi-perineal neuralgia (>3 months) with a DN4 score ≥4 at the inclusion visit, with or without symptoms of central sensitization, and with an indication for topical treatment with high-concentration capsaicin patch (PCHC).
- Patients who have signed the informed consent form for the study at the inclusion visit.
- Women must meet one of the following criteria at the time of inclusion:
- Use adequate contraceptive measures;
- or Be postmenopausal (aged over 50 years with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal treatments);
- or (If aged under 50 years) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal treatments, with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal levels;
- or Have undergone irreversible surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), with documentation of the procedure.
Who cannot join
- Patients under guardianship, curatorship, or legal protection.
- Pregnant or breastfeeding women.
- Patients with contraindications to the use of the high-concentration capsaicin patch (PCHC): application on damaged skin, hypersensitivity to any of its components.
- Patients simultaneously starting a treatment that may influence central sensitization (e.g., antidepressants, antiepileptics, psychotherapy, physical activity, transcutaneous electrical nerve stimulation).
- Patients not affiliated with the French Social Security system.
- Patients with insufficient cooperation and/or understanding to strictly comply with the protocol requirements.
- Patients who have taken analgesics within the 12 hours prior to measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The primary objective of this study will be to demonstrate a change in pain sensitization parameters before and after the application of the high-concentration capsaicin patch.
Read the detailed description
Category 2 Study (Interventional Research with Minimal Risks and Constraints), monocentric, uncontrolled, non-randomized, open-label and prospective.
This study involves conducting tests and questionnaires before and 1 month after the application of a patch administered as part of standard clinical practice.
- Conditions
- Neuropathic Pain, Nociplastic Pain
- Being tested
- Quantitative Sensory Testing and questionnaires
- Keywords
- Sensitization, 8% capsaicin patch, Quantitative Sensory Testing, Temporal Summation
- Medical subject headings
- Neuralgia, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Testing and questionnairesOther
Quantitative Sensory Testing and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Pain sensitization parameter testing | Experimental | Pre-inclusion visit (routine care consultation): Verification of inclusion and exclusion criteria.
Inclusion visit (Day 0): Consent signing, questionnaires (ConvergencePP Score/Central Sensitization Inventory, DN4), and a series of tests, followed by the application of the high-concentration capsaicin patch (PCHC) (performed during routine care).
Day 30 visit (±7 days): Questionnaires (same as V1 + PGI-c) and a series of tests. Receives: Other: Quantitative Sensory Testing and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criterion
Composite criterion constructed from a Principal Component Analysis including the differences between Day 0 (before patch application) and Day 30 in pain perception thresholds (to cold, heat, pressure, and mechanical stimulation) in both the area treated with the high-concentration capsaicin patch and the corresponding dermatome, as well as the change in the pain receptive field area in the treated zone and the area under the curve of temporal summation measurements.
Measured: Difference between Day 0 and Day 30
Secondary outcomes (14)
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
Difference in pressure pain thresholds in the treated area
Measured: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)
Difference in mechanical stimulation pain thresholds
Measured: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)
Difference in cold pain thresholds in the treated area
Measured: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)
Difference in heat pain thresholds in the treated area
Measured: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5)
Difference in pain receptive field area
Measured: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1)
Difference in pressure pain thresholds in an area of the dermatome not directly treated by the patch:
- Ipsilateral retro-malleolar groove (S2 root) for inferior cluneal nerve neuralgia treatment,
- Posterior iliac crest relief, 7 cm from the midline (L1) for ilio-inguinal or ilio-hypogastric neuralgia treatment,
- Perineal body (S4) for sacrococcygeal plexus neuralgia treatment.
Measured: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2)
Difference in mechanical stimulation pain thresholds in an area of the dermatome not directly treated by the patch
Measured: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3)
Difference in cold pain thresholds in an area of the dermatome not directly treated by the patch.
Measured: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4)
Difference in heat pain thresholds in an area of the dermatome not directly treated by the patch.
Measured: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5)
Difference in the area under the curve of temporal summation measurements in the treated area
Measured: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6)
Difference in the duration of pain persistence after the end of temporal summation (in seconds).
Measured: Between before and 1 month after patch application.
Measure the patient's therapeutic response to the treatment
Patient Global Impression of Change (PGI-C). The therapeutic response is defined as a patient who scores 1 to 3 on the PGI-C.
Measured: Day 30
Evaluate the predictive value of temporal summation with regard to the therapeutic response to the high-concentration capsaicin patch
Investigation of a relevant threshold for temporal summation to predict the therapeutic response. Quantification of the positive predictive value.
Measured: Between before and 1 month after patch application.
Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data
Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data. The Convergences PP score is a clinical questionnaire used to diagnose sensitization in the pelvic region. A score is considered positive from 5/10 (sensitivity = 95%, specificity = 87%).
The Central Sensitization Inventory (CSI) is a self-administered questionnaire used to diagnose central sensitization. A score is considered positive from 40/100.
Correlations between the Convergences PP score, CSI, and semi-objective sensitization data (pain thresholds and temporal summation) will be measured using Spearman's correlation coefficient to explore the relationships between these variables.
Measured: Between before and 1 month after patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660510
- Sponsor's protocol ID
- RC25_0536
- Acronym
- CAPSASENS
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches
- ClinicalTrials.gov ID
- NCT07660510
- Acronym / sponsor ID
- CAPSASENS / RC25_0536
- Conditions
- Neuropathic Pain, Nociplastic Pain
- Keywords
- Sensitization, 8% capsaicin patch, Quantitative Sensory Testing, Temporal Summation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 22 Jun 2026 (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.
The primary objective of this study will be to demonstrate a change in pain sensitization parameters before and after the application of the high-concentration capsaicin patch.
Detailed description
Category 2 Study (Interventional Research with Minimal Risks and Constraints), monocentric, uncontrolled, non-randomized, open-label and prospective.
This study involves conducting tests and questionnaires before and 1 month after the application of a patch administered as part of standard clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain sensitization parameter testing | Experimental | Other: Quantitative Sensory Testing and questionnairesPre-inclusion visit (routine care consultation): Verification of inclusion and exclusion criteria. Inclusion visit (Day 0): Consent signing, questionnaires (ConvergencePP Score/Central Sensitization Inventory, DN4), and a series of tests, followed by the application of the high-concentration capsaicin patch (PCHC) (performed during routine care). Day 30 visit (±7 days): Questionnaires (same as V1 + PGI-c) and a series of tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women ≥ 18 years old.
- Patients suffering from chronic pelvi-perineal neuralgia (>3 months) with a DN4 score ≥4 at the inclusion visit, with or without symptoms of central sensitization, and with an indication for topical treatment with high-concentration capsaicin patch (PCHC).
- Patients who have signed the informed consent form for the study at the inclusion visit.
- Women must meet one of the following criteria at the time of inclusion:
- Use adequate contraceptive measures;
Key exclusion criteria (7 listed)
- Patients under guardianship, curatorship, or legal protection.
- Pregnant or breastfeeding women.
- Patients with contraindications to the use of the high-concentration capsaicin patch (PCHC): application on damaged skin, hypersensitivity to any of its components.
- Patients simultaneously starting a treatment that may influence central sensitization (e.g., antidepressants, antiepileptics, psychotherapy, physical activity, transcutaneous electrical nerve stimulation).
- Patients not affiliated with the French Social Security system.
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 |
|---|---|---|
| Quantitative Sensory Testing and questionnairesQuantitative Sensory Testing and questionnaires | Other | Pain sensitization parameter testing |
Primary outcome
Composite criterion
Time frame: Difference between Day 0 and Day 30
Composite criterion constructed from a Principal Component Analysis including the differences between Day 0 (before patch application) and Day 30 in pain perception thresholds (to cold, heat, pressure, and mechanical stimulation) in both the area treated with the high-concentration capsaicin patch and the corresponding dermatome, as well as the change in the pain receptive field area in the treated zone and the area under the curve of temporal summation measurements.
14 secondary outcomes
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (1)
Time frame: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (2)
Time frame: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (3)
Time frame: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (4)
Time frame: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch on peripheral sensitization (5)
Time frame: Between before and 30 days after patch application
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (1)
Time frame: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (2)
Time frame: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (3)
Time frame: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (4)
Time frame: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (5)
Time frame: Between before and 1 month after patch application.
Measure the effect of the high-concentration capsaicin patch (PCHC) on spinal sensitization (6)
Time frame: Between before and 1 month after patch application.
Measure the patient's therapeutic response to the treatment
Time frame: Day 30
Evaluate the predictive value of temporal summation with regard to the therapeutic response to the high-concentration capsaicin patch
Time frame: Between before and 1 month after patch application.
Measure the correlation between Convergences PP scores, CSI, and semi-objective sensitization data
Time frame: Between before and 1 month after patch application
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 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Sensory Testing and questionnaires in people with Neuropathic Pain and Nociplastic Pain, run by Nantes University Hospital at 1 site 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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Amélie LEVESQUE, MD (+33240083912, amelie.levesque@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite criterion (time frame: Difference between Day 0 and Day 30). 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 22 Jun 2026.