Amputations in Childhood and Neuropathic Pain (NAPE)

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Neuropathic Pain; Phantom Limb Pain; Pediatric

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Auriane AS SLAMA; Phone Number: +33607317969 +33143967556; Email: auriane.slama@ght94n.fr

Study Locations

• France
  • Saint-Maurice, France, 94410
    • Recruiting
    • Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
    • Contact: Margaux MM Modjbafan; Phone Number: +33143966643; Email: margaux.modjbafan@ght94n.fr
    • Contact: Maïwenn MF Feldmann; Phone Number: +33143966643; Email: maiwenn.feldmann@ght94n.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children and adolescents aged 5 to 18 years who underwent limb amputation during childhood and are followed at a specialized pediatric referral center for limb anomalies.

Participants include individuals with upper limb and/or lower limb amputation, regardless of the etiology of amputation. The study population includes both prosthesis users and non-prosthesis users. Data are collected using retrospective medical record review and a single prospective assessment with standardized questionnaires administered during routine follow-up visits, without any modification of standard clinical care.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Pediatric limb amputation cohort; This cohort includes children and adolescents aged 5 to 18 years who underwent limb amputation during childhood and are followed at a specialized pediatric limb anomaly referral center. Participants are evaluated at a single time point using retrospective medical record data and standardized questionnaires administered during routine follow-up visits, without any modification of standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of neuropathic pain after pediatric limb amputation	Presence of neuropathic pain assessed using the DN4 questionnaire, including phantom limb pain and residual limb pain. A DN4 score of 4 or higher is considered indicative of neuropathic pain.	Single assessment at study inclusion (variable time after amputation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of neuropathic pain after pediatric limb amputation	Type of neuropathic pain reported after limb amputation, distinguishing phantom limb pain and residual limb pain, assessed using the DN4 questionnaire.	At study inclusion
Health-related quality of life	Health-related quality of life assessed using the SF-15 Generic Core Scales questionnaire, adapted to the participant's age, in children and adolescents with limb amputation.	At study inclusion
Locomotor capability in lower limb amputees	Locomotor capability assessed using the Locomotor Capability Index (LCI) in children and adolescents with lower limb amputation. The LCI score is analyzed in prosthesis users, for whom the scale is validated. For non-prosthesis users, a descriptive analysis of individual items is performed.	At study inclusion
Upper limb functional ability	Upper limb functional ability assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in children and adolescents with upper limb amputation.	At study inclusion
Correlation between DN4 neuropathic pain score and SF-15 health-related quality of life score	Neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire (score range 0-10; score ≥4 indicating neuropathic pain). Health-related quality of life will be assessed using the SF-15 Generic Core Scales questionnaire (score range 0-100; higher scores indicating better quality of life). The correlation between DN4 total score (continuous variable) and SF-15 total score (continuous variable) will be analyzed using Pearson or Spearman correlation coefficients, as appropriate. The strength of correlation will be expressed as Pearson or Spearman correlation coefficient (r), ranging from -1 to +1.	At study inclusion
Correlation between DN4 neuropathic pain score and functional outcome scores (LCI and QuickDASH)	Neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire (score range 0-10; higher scores indicate greater neuropathic pain). Functional outcomes will be assessed using: Locomotor Capability Index (LCI) in lower limb amputees (score range 0-100; higher scores indicate better locomotor capability) Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in upper limb amputees (score range 0-100; higher scores indicate greater disability). Correlations between DN4 total score and functional outcome scores will be analyzed using Pearson or Spearman correlation coefficients (r).	At study inclusion
Correlation between DN4 neuropathic pain score and age at amputation	Neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire (score range 0-10; higher scores indicate greater neuropathic pain). Age at amputation (years) will be recorded from medical records. Correlation between DN4 total score and age at amputation will be analyzed using Pearson or Spearman correlation coefficients (r).	At study inclusion

Collaborators and Investigators

• Sponsor: Hopitaux de Saint-Maurice
• Investigators: Principal Investigator: Margaux MM Modjbafan, Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410; Study Director: Maïwenn MF Feldmann, Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia; Phantom Limb
• Other Study ID Numbers: NAPE; 2025-A02122-47 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the observational design of the study, the pediatric population involved, and the need to protect sensitive medical and functional data. Data are pseudonymized and handled in accordance with applicable data protection regulations, and no public data-sharing plan is planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No