Neuropathic pain after childhood amputation
Amputations in Childhood and Neuropathic Pain
This project sees how common phantom and residual limb neuropathic pain is and how it affects children and teens who had limb amputations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Hopitaux de Saint-Maurice Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Saint-Maurice) |
| Trial ID | NCT07401966 on ClinicalTrials.gov |
What this trial studies
This monocentric observational study uses a mixed retrospective and prospective design to document phantom limb pain and residual limb pain in children and adolescents who underwent limb amputation during childhood. Data are collected from medical records and age-appropriate standardized questionnaires administered at routine follow-up visits at a specialized pediatric limb anomaly center. The study also measures quality of life and functional autonomy and explores associations with age at amputation and surgical history. Results aim to clarify the prevalence, characteristics, and everyday impact of neuropathic pain in this rare population.
Who should consider this trial
Good fit: Children and adolescents aged 5–18 who had a limb amputation before age 15 for girls or 16 for boys, can complete self-report questionnaires in French, have not had surgery on the amputated limb within the past year, and have parental consent.
Not a fit: Patients who may not benefit include non-French speakers, those with insufficient cognitive ability to complete questionnaires, patients currently receiving chemotherapy, adults, or those who had recent surgery on the amputated limb.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify neuropathic pain earlier and guide prevention and management strategies to improve prosthetic use and quality of life.
How similar studies have performed: While adult studies have documented phantom and residual limb neuropathic pain, pediatric data are limited, so applying validated questionnaires in children is relatively novel but builds on adult evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 5 and 18 years (inclusive) (Piaget's concrete operational stage to be able to complete the self-assessment questionnaires) * Patients who underwent amputation before the age of 15 for girls and 16 for boys (average age of completion of lower limb growth) * Patients who have not undergone surgery on the amputated limb for at least one year (to avoid bias, as any surgery involving incision can cause temporary neuropathic pain unrelated to the amputation) * Have obtained the signature of the non-objection form by both parents/legal guardians * Have obtained the child's consent (verbal consent but recorded) * Be affiliated with a health insurance plan. Exclusion Criteria: * Patients who do not speak French * Patients whose cognitive abilities are insufficient (as determined by a clinician or reported by parents) to be able to complete self-assessment questionnaires * Patients undergoing chemotherapy (due to transient neuropathic pain) * Patients who have received chemotherapy and whose side effects have not yet subsided (on a case-by-case basis depending on the chemotherapy used) * Patients who have received chemotherapy causing neuropathic pain due to this treatment that has not disappeared. * Patients placed under protective custody.
Where this trial is running
Saint-Maurice
- Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres — Saint-Maurice, France (Recruiting)
Study contacts
- Principal investigator: Margaux MM Modjbafan — Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410
- Study coordinator: Auriane AS SLAMA
- Email: auriane.slama@ght94n.fr
- Phone: +33143967556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.