Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old (CAPSULE)

Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Neuropathic Pain
• Intervention / Treatment: Other: Data collection

Detailed 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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Philippe J LE MOINE, MD; Phone Number: +33298223956; Email: philippe.lemoine@chu-brest.fr

Study Locations

• France
  • Amiens, France, 80054
    • Not yet recruiting
    • CHU d'Amiens
    • Contact: Sandrine SORIOT-THOMAS; Phone Number: +33322087997; Email: soriot-thomas.sandrine@chu-amiens.fr
  • Angers, France, 49933
    • Not yet recruiting
    • CHU Angers
    • Contact: Petronela Rachieru Sourisseau, MD; Phone Number: +33241355741; Email: perachieru@chu-angers.fr
  • Bordeaux, France, 33076
    • Recruiting
    • Chu Bordeaux
    • Contact: Sylvie Berciaud, MD; Phone Number: +33557820194; Email: sylvie.berciaud@chu-bordeaux.fr
  • Bourg-en-Bresse, France, 01000
    • Not yet recruiting
    • CHR Bourg en Bresse
    • Contact: Clémence Dal-Col, MD; Phone Number: +33474454357; Email: cdalcol@ch-bourg01.fr
  • Brest, France, 29609
    • Recruiting
    • CHU de BREST
    • Contact: Philippe J LE MOINE, MD; Phone Number: +33298223956; Email: philippe.lemoine@chu-brest.fr
  • Caen, France, 14000
    • Recruiting
    • CHU CAEN
    • Contact: Alexandra Desdoits, MD; Phone Number: +33231064486; Email: desdoits-a@chu-caen.fr
  • Grenoble, France, 38043
    • Not yet recruiting
    • CHU Grenoble
    • Contact: Mariel Cartal, MD; Phone Number: +33476767987; Email: mcartal@chu-grenoble.fr
  • Lille, France, 59037
    • Recruiting
    • CHU Lille
    • Contact: Justine Avez-Couturier, MD; Phone Number: +33320444671; Email: justine.couturier@chru-lille.fr
  • Limoges, France, 87042
    • Not yet recruiting
    • CHU Limoges
    • Contact: Christophe Piguet, MD; Phone Number: +33555056801; Email: christophe.piguet@chu-limoges.fr
  • Lyon, France
    • Recruiting
    • CHU Lyon
    • Contact: Sabine Simonin, MD; Phone Number: +33472118866; Email: sabine.simonin@chu-lyon.fr
  • Marseille, France, 13005
    • Recruiting
    • CHU Marseille
    • Contact: Cécile Mareau, MD; Phone Number: +33491386302; Email: cecile.mareau@ap-hm.fr
  • Montpellier, France, 34090
    • Recruiting
    • CHU Montpellier
    • Contact: Frédéri Bernard, MD; Email: f-bernard@chu-montpellier.fr
  • Nancy, France, 54511
    • Not yet recruiting
    • CHU Nancy
    • Contact: Ludovic Mansuy, PHD; Phone Number: +33383154734; Email: lu.mansuy@chru-nancy.fr
  • Nantes, France, 44093
    • Recruiting
    • CHU Nantes
    • Contact: Marine Letellier; Phone Number: +33240083610; Email: marine.letellier@chu-nantes.fr
  • Paris, France, 75019
    • Not yet recruiting
    • CHU Robert Debré
    • Contact: Esther Soyeux, MS; Phone Number: +33140034102; Email: esther.soyeux@aphp.fr
  • Paris, France, 75571
    • Not yet recruiting
    • CHU Trousseau
    • Contact: Barbara Tourniaire, MD; Phone Number: +33144737392; Email: barbara.tourniaire@aphp.fr
  • Rouen, France, 76031
    • Recruiting
    • CHU Rouen
    • Contact: Alice Petit-Ledo, MD; Phone Number: +33232885898; Email: alice.petit-ledo@chu-rouen.fr
  • Strasbourg, France, 67098
    • Recruiting
    • CHRU Strasbourg
    • Contact: Mathieu REBERT, MD; Email: Mathieu.rebert@chru-strasbourg.fr
  • Toulouse, France, 31059
    • Recruiting
    • CHU Toulouse
    • Contact: Agnès Suc, MD; Phone Number: +33534558661; Email: suc.a@chu-toulouse.fr
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
    • Contact: Marie-Anne Sevèque Sevèque, MD; Phone Number: +33142114433; Email: marie-anne.seveque@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients aged less than 18-y with chronic localized neuropathic pain and capsaicin 8% patch indication validated in a pediatric chronic pain center.

patient with intellectual development disabilities are accepted

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indication of capsaicin use	Indication for treatment with capsaicine will be collected (context of emergence of pain, descriptive data)	At recruitment visit
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Tolerance assessment (duration of patch application)	Duration of patch application in minutes	Baseline, 3 months and 6 months
Tolerance assessment (number of patch used)	Number of patch used during the application	Baseline, 3 months and 6 months
Tolerance assessment (cutaneous state)	Cutaneous state (burning, erythema, healthy skin, other) just after patch removal	Baseline, 3 months and 6 months
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Fondation Apicil; Fondation de France
• Investigators: Principal Investigator: Philippe J Le Moine, MD, CHRU of Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): September 12, 2027

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 22, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Neuropathic Pain; Capsaicin
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia
• Other Study ID Numbers: 29BRC21.0184 (CAPSULE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No