Incidence and Factors Affecting the Development and Outcome of Phantom Limb Pain (PLP) - A Single-centre Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Incidence of Phantom Limb Pain
研究概览
简要总结
Phantom limb pain (PLP), defined as pain felt in the missing portion of the amputated limb following amputation, occurs in a significant percentage of patients who undergo limb amputation and it is among the most difficult chronic pain syndromes to treat. Its incidence has been reported to be around 70% though a local pilot study in 2013 reported the incidence to be 25%. The investigators aim to determine the actual incidence of PLP by conducting a single-centre prospective cohort study and identify risk factors associated with PLP. Subsequently, the investigators will use identified risk factors to develop and validate a risk prediction model for PLP after amputation surgery and design interventional studies aimed at reducing the development of PLP in high risk patients.
详细描述
Specific aims:
By using prospective design and validated multidimensional pain questionnaire, the investigators aim to better estimate the true incidence of PLP, other associated risk factors and the severity of functional impairment.
This study is divided into 2 phases, of which the first phase of the study would be covered by the scope of the grant.
Phase 1 Primary Aim 1. To determine the local incidence of PLP at 3 months post amputation surgery (as literature suggests that PLP is most likely to develop within 3 months of amputation surgery) Hypothesis It is hypothesized that the incidence of PLP is estimated to be 41-85% from the literature .
Secondary Aims 1. Analyse and delineate modifiable and non-modifiable risk factors (patient, anaesthetic and surgical factors) contributing to the development of PLP. 2. Identify factors likely to prevent or reduce the development of PLP after amputation surgery 3. To identify factors prognosticating patient outcomes and recovery from PLP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of Phantom Limb Pain
时间窗: 3 months
Phantom Limb Pain
次要结局
未报告次要终点