Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07401966

Amputations in Childhood and Neuropathic Pain

Status
Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Hopitaux de Saint-Maurice · Academic / Other
Sex
All
Age
5 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This observational study aims to assess the presence of neuropathic pain in children and adolescents who underwent limb amputation during childhood. The study focuses on two types of neuropathic pain: phantom limb pain and residual limb pain. It also evaluates quality of life and functional autonomy in this population and explores potential associations between neuropathic pain, autonomy, quality of life, and age at amputation. Using a mixed retrospective and prospective design, data are collected from medical records and standardized questionnaires administered during routine follow-up visits at a specialized pediatric limb anomaly center. The study seeks to improve understanding of neuropathic pain after pediatric amputation and its impact on daily functioning.

Detailed description

Pediatric limb amputations are rare and may occur in the context of trauma, infection, tumors, or congenital malformations. In some congenital conditions, such as proximal femoral focal deficiency, therapeutic amputation may be proposed to improve prosthetic fitting, functional outcomes, and autonomy. One of the potential complications associated with limb amputation is the development of neuropathic pain, including phantom limb pain and residual limb pain. While these conditions are well documented in adults, their prevalence and impact in pediatric populations remain poorly understood. Neuropathic pain may interfere with prosthetic use, functional abilities, quality of life, and long-term autonomy. In children who undergo amputation for functional purposes, the presence and consequences of neuropathic pain are important factors to consider when weighing the expected benefits of surgery. Early identification and management of neuropathic pain may also allow better anticipation and implementation of preventive or therapeutic strategies. This monocentric observational study aims to describe the presence of neuropathic pain in children and adolescents who underwent limb amputation during childhood. Neuropathic pain is assessed using validated questionnaires, distinguishing between phantom limb pain and residual limb pain. The study also evaluates quality of life and functional autonomy using age-appropriate standardized assessment tools. In addition, the study explores associations between neuropathic pain and functional autonomy, quality of life, age at amputation, and preoperative preventive treatments when applicable. Data are collected through a mixed retrospective and prospective approach, combining extraction of medical record information and a single administration of questionnaires during routine follow-up visits. No intervention or modification of standard clinical care is performed. By providing descriptive data on neuropathic pain and its functional consequences after pediatric amputation, this study aims to contribute to improved clinical decision-making, pain management strategies, and long-term follow-up of children with limb amputations.

Conditions

Timeline

Start date
2026-02-19
Primary completion
2026-11-09
Completion
2027-02-02
First posted
2026-02-11
Last updated
2026-02-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07401966. Inclusion in this directory is not an endorsement.