Amputations in Childhood and Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Presence of neuropathic pain after pediatric limb amputation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Presence of neuropathic pain after pediatric limb amputation
时间窗: 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.
次要结局
- 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)
- Correlation between DN4 neuropathic pain score and functional outcome scores (LCI and QuickDASH)(At study inclusion)
- Correlation between DN4 neuropathic pain score and age at amputation(At study inclusion)