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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05299294
Other study ID # 29BRC21.0184 (CAPSULE)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 12, 2022
Est. completion date September 12, 2027

Study information

Verified date May 2024
Source University Hospital, Brest
Contact Philippe J Le Moine, MD
Phone +33298223956
Email philippe.lemoine@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study . Medical data will be recorded and at home, the child or his family will collect pain assessment data. Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.


Description:

Children and teenagers aged less than 18-y, with chronic localized neuropathic pain, may be treated by capsaicin 8% patch. If this indication is validated in pediatric chronic pain consultation, they will be offered to participate the study. If they accept it as well as their parents, they will be included in the study. Treatment application will follow recommendations and be realized in out patient clinic with trained nurses. Tolerance will be assessed by phone call every 24 Hours by investigational team until normalization. Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data. Efficacy will be monitored with usual pain and neuropathic pain tools, adapted to age and cognitive capacities, one month after application. Treatment may be done three times if needed with a three month interval between each capsaicin patch application.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date September 12, 2027
Est. primary completion date May 12, 2027
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - chronic localized neuropathic pain - capsaicin 8% patch treatment indication validated in a pediatric chronic pain center - agreement for participation by child and parents Exclusion Criteria: - already treated with capsaicin 8% patch in the same body area - already treated in the same study in an other investigation center - non willing to participate or parents not willing participation to the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain

Locations

Country Name City State
France CHU d'Amiens Amiens
France CHU Angers Angers
France CHU Bordeaux Bordeaux
France CHR Bourg en Bresse Bourg-en-Bresse
France CHU de Brest Brest
France CHU Caen Caen
France CHU Grenoble Grenoble
France CHU Lille Lille
France CHU Limoges Limoges
France CHU Lyon Lyon
France CHU Marseille Marseille
France CHU Montpellier Montpellier
France CHU Nancy Nancy
France CHU Nantes Nantes
France CHU Robert Debré Paris
France CHU Trousseau Paris
France CHU Rouen Rouen
France CHRU Strasbourg Strasbourg
France CHU Toulouse Toulouse
France Institut Gustave Roussy Villejuif

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Brest Fondation Apicil, Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success or failure of pain treatment : Number of patients with success and number of patients with failure of treatment with capsaicin The success is defined by the absence of use of pain medication during the three months after the end of capsaicin application protocol 3 months after last patch application
Secondary Indication of capsaicin use Indication for treatment with capsaicine will be collected (context of emergence of pain, descriptive data) At recruitment visit
Secondary Success or failure of pain treatment : Number of patients who use or not use antalgic and/or comfort medication (including for improving sleep) Use of antalgic and/or comfort medication (including for improving sleep). Success is de fined by the non use of antalgic and/or comfort medication (including for improving sleep) Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain evaluation for child aged from 0 to 4 years Score of HECP (Hetero-Evaluation of Child Pain) questionnaire, score from 0 to 10 (a higher score means a worse outcome) Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain evaluation for child with intellectual deficiency Score of PAGID (Pain Assessment Grid - Intellectual Deficiency) or PPP (Pediatric Pain Profile) questionnaire, higher scores are worse outcome Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain description for child aged from 5 to 11 years Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory), questionnaire with support, score from 0 to 100, higher score is worse outcome Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain diagnostic for child aged from 5 to 11 years Global score of pPN4 (Paediatric Neuropathic Pain 4 points) questionnaire, score from 0 to 10, higher score is worse item Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain evaluation for child aged from 5 to 11 years Score of pVAS (Paediatric Visual Analogic Scale) or NS (Numeric Scale) or Revised Faces Pain Scales, score from 0 to 10, higher score is worse outcome Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain description for child aged from 12 to 17 years Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain evaluation for child aged from 12 to 17 years Score of VAS (Visual Analogic Scale) or NS (Numeric Scale), score from 0 to 10, higher score is worse outcome Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary Neuropathic pain diagnostic for child aged from 12 to 17 years Global score of NP4 questionnaire (Neuropathic Pain 4 points), score from 0 to 10, higher score is worse item Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Functional disability evaluation for child aged from 5 to 17 years Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Pain description for child aged from 5 to 17 years : number of painful access Number of painful access (crisis) in one day Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Pain description for child aged from 5 to 17 years : duration of painful access Mean duration of painful access (crisis) in minutes Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Pain description for child aged from 5 to 17 years : trigger factor of the painful access Type of trigger factor that leads to the painful access Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Pain description for child aged from 5 to 17 years : sensation Description of sensation reported by the child (sensation spontaneously described, qualitative data) Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Pain description (observed signs) for child aged from 0 to 4 years or with intellectual deficiency Description of observed signs related to pain Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Pain description (sleep quality) for child aged from 0 to 4 years or with intellectual deficiency Description of sleep quality (night awakening / week) Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Pain description (child behaviour) for child aged from 0 to 4 years or with intellectual deficiency Description of child behaviour related to pain (antalgic position) Baseline and 1 month, 3 months and 6 months after patch application.
Secondary Tolerance assessment (duration of patch application) Duration of patch application in minutes Baseline, 3 months and 6 months
Secondary Tolerance assessment (number of patch used) Number of patch used during the application Baseline, 3 months and 6 months
Secondary Tolerance assessment (cutaneous state) Cutaneous state (burning, erythema, healthy skin, other) just after patch removal Baseline, 3 months and 6 months
Secondary Tolerance assessment (skin aspect) Local aspect of skin : presence of erythema Yes or No, in the hours and days following patch application Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
Secondary Tolerance assessment (icing) Need for icing (YES/NO) against pain Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
Secondary Tolerance assessment (rescue medication) Intake of rescue medication against pain (YES/NO) Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
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