Amputations in Childhood and Neuropathic Pain

NCT07401966 | Recruiting

• 2 other identifiers: NAPE2025-A02122-47
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric; Neuropathic Pain; Phantom Limb Pain; Amputation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Type of neuropathic pain after pediatric limb amputation

  At study inclusion

• Health-related quality of life

  At study inclusion

• Locomotor capability in lower limb amputees

  At study inclusion

• Upper limb functional ability

  At study inclusion

• Correlation between DN4 neuropathic pain score and SF-15 health-related quality of life score

  At study inclusion

Study Arms (1)

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.

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopitaux de Saint-Maurice: lead

Study Sites (1)

Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres

Saint-Maurice, 94410, France

RECRUITING

MeSH Terms

Conditions

Neuralgia; Phantom Limb

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes

Study Officials

• Margaux MM Modjbafan

  Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410

  PRINCIPAL INVESTIGATOR

• Maïwenn MF Feldmann

  Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410

  STUDY DIRECTOR

Central Study Contacts

Auriane AS SLAMA

CONTACT

+33143967556; auriane.slama@ght94n.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 11, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): February 2, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)