PediatricNAPENCT07401966
Amputations in Childhood and Neuropathic Pain
An observational study of Pediatric and Neuropathic Pain, run by Hopitaux de Saint-Maurice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pediatric, Neuropathic Pain, Phantom Limb Pain
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2026to 2 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
Saint-Maurice, 94410
Margaux MM Modjbafan, +33143966643, margaux.modjbafan@ght94n.fr
Maïwenn MF Feldmann, +33143966643, maiwenn.feldmann@ght94n.fr
About this study
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.
Read the 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
- Pediatric, Neuropathic Pain, Phantom Limb Pain, Amputation
- Medical subject headings
- Neuralgia, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single assessment at study inclusion (variable time after amputation)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: At study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start19 Feb 2026
- Primary completion9 Nov 2026 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaux MM Modjbafan, Principal investigator, Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410Maïwenn MF Feldmann, Study director, Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401966
- Sponsor's protocol ID
- NAPE
- Other IDs
- 2025-A02122-47
- Acronym
- NAPE
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amputations in Childhood and Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07401966
- Acronym / sponsor ID
- NAPE / NAPE
- Conditions
- Pediatric, Neuropathic Pain, Phantom Limb Pain, Amputation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 9 Nov 2026 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of neuropathic pain after pediatric limb amputation
Time frame: Single assessment at study inclusion (variable time after 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaux MM Modjbafan principal investigator
Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410
Maïwenn MF Feldmann study director
Hôpitaux Paris Est Val-de-Marne, centre de référence des malformations des membres, Saint-Maurice 94410
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric and Neuropathic Pain, run by Hopitaux de Saint-Maurice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Auriane AS SLAMA (+33143967556 ext. +33607317969, auriane.slama@ght94n.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of neuropathic pain after pediatric limb amputation (time frame: Single assessment at study inclusion (variable time after amputation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.