Amputations in Childhood and Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pediatric, Neuropathic Pain, Phantom Limb Pain, Amputation. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Presence of neuropathic pain after pediatric limb amputation [Time frame: Single assessment at study inclusion (variable time after amputation)]
Secondary outcome measures (7)
- Type of neuropathic pain after pediatric limb amputation [Time frame: At study inclusion]
- Health-related quality of life [Time frame: At study inclusion]
- Locomotor capability in lower limb amputees [Time frame: At study inclusion]
- Upper limb functional ability [Time frame: At study inclusion]
- Correlation between DN4 neuropathic pain score and SF-15 health-related quality of life score [Time frame: At study inclusion]
- Correlation between DN4 neuropathic pain score and functional outcome scores (LCI and QuickDASH) [Time frame: At study inclusion]
- Correlation between DN4 neuropathic pain score and age at amputation [Time frame: At study inclusion]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres — Saint-Maurice
Identifiers
NCT: NCT07401966 · NAPE · 2025-A02122-47