Amputations in Childhood and Neuropathic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-18
SponsorHopitaux de Saint-Maurice
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Pediatric limb amputation cohort
Trial outcomes
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.
Time frame
Single assessment at study inclusion (variable time after amputation)Secondary outcomes
1
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.
Time frame
At study inclusion2
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.
Time frame
At study inclusion3
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.
Time frame
At study inclusion4
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.
Time frame
At study inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov