Neuropathic Pain, Chronic Pain
Conditions
Keywords
Neuropathic Pain, Pediatric, Capsaicin, Randomized clinical trial
Brief summary
This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery. It is a multicentric randomized controlled superiority trial in parallel arms : * experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed. Tolerance is assessed during each application and by phone call in following days until stop of cold need. Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).
Detailed description
Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the designed investigation centers for a local chronic neuropathic pain lasting more than 2 months after trauma or surgery are proposed to participate the trial. Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) \> or = 3/7 ou DN4 \>or = 4/10) despite oral treatment following recommendations for neuropathic pain may be enrolled in the study. For children not very painful (NRS-11 (Numeric Rating Scale) \< 7 and FDI (Functional Disability Inventory) \< 30) and without any oral treatment for neuropathic pain, the study may be proposed as first line treatment. If both the child and his/her parents accept the trial, he/she will be included in the study. It is a multicentric randomized controlled superiority trial in parallel arms : * experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing At M0, take place : baseline evaluation, agreement consent signature, inclusion and randomization, as well as first treatment application either capsaicin cutaneous patch or hydrocolloid dressing. , If needed, the treatment may be done twice with a second application three months later (M3). Tolerance is assessed during each application and by phone call in following days until stop of cold need. Efficacy is assessed monthly by clinical consultation until the end of the study 4 months later (M4).
Interventions
Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.
DEVICEHydrocolloid dressing
Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
There is no mock cutaneous patch available for capsaicin 8% cutaneous patch. So we have chosen hydrocolloid dressing for placebo since it has no known effect on neuropathic pain and the tolerability is expected as excellent. The patient should not be aware of the specific aspect of capsaicin 8% patch and the protocol of application will be exactly the same. This should keep the patient blinded for the study treatment. The nurse who applies the patch is unblinded.
Intervention model description
Multicentric randomized controlled superiority trial in parallel arms: * experimental arm : Capsaicin 8% cutaneous patch * control arm : Hydrocolloid dressing
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling). * Male or female. * Persistent neuropathic pain more than 3 months after surgery or trauma despite treatment following recommendations. * Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma. * Treatment, survey and follow up must be realized in an identified investigating center of the study * For patients of childbearing potential: use of an adequate method of contraception\* during the course of the study through 48 hours after the last patch application (girls of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first patch application). * Adequate contraception includes sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide, combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods)
Exclusion criteria
* Intellectual deficiency not allowing full filling of NPSI. * Insufficient command of the French language to full fill NPSI and other evaluation tools. * Parents' refusal of consent. * Minor patients' opposition. * Underlying neurological disease. * Ongoing neurotoxic treatment. * Already treated by capsaicin. * Cutaneous lesion on pain area. * Patient presenting a pain area on the face, above the hairline of the scalp, and/or in proximity to mucous membranes * Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Qutenza SmPC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Neuropathic Pain Symptom Inventory score (NPSI) | At baseline (day of the patch application) and 4 months after patch application | The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4). NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | At baseline, Month 1, Month 2, Month 3 and Month 4 | Cardiac frequency in Bpm |
| Dermal assessment | At baseline | Dermal assessment is evaluated with question concerning the treated area (YES/NO) |
| Treatment related pain and use of analgesic medication | At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4 | Intake of analgesic medication (YES/NO) |
| Adverse event monitoring | At day 0, day 1, day 2, day 3 after patch application | Adverse event monitoring are collected during patch application and by phone calls in the following days. |
| Neuropathic Pain Symptom Inventory score (NPSI) | At baseline, Month 1, Month 2, Month 3 and Month 4 | Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome |
| Functional disability evaluation (FDI) | At baseline, Month 1, Month 2, Month 3 and Month 4 | Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome |
| Duration of patch application | During patch application : at baseline and at Month 3 if it is applicable | Duration of patch application in minutes |
Countries
France
Contacts
Primary ContactPhilippe J LE MOINE, MD
Outcome results
None listed