Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 11
- 主要终点
- Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)
研究概览
简要总结
Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)
详细描述
The aim of this study is to develop and validate a French self-questionnaire to diagnose parkinsonian primary : the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ). It will allow clinicians to distinguish this pain from the other pain of the parkinsonian patient (whether or not related to Parkinson's disease).
The development and validation of the 3PDQ self-questionnaire will take place in 3 sequential steps:
- design of the self-questionnaire
- appearance validity study
- validation of the self-questionnaire
Participants :
Appearance validity study: 40 painful parkinsonian patients Validation study: 200 painful parkinsonian patients (10 patients per item)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson Disease (PD)
- •Patients who have chronic pain (for at least 3months) moderate to severe (intensity ≥ 4/10 on visual analogue scale from 0 to 10) specific or unspecific to PD
- •Patients who have one type of pain or different type of pain: in this case, patients should suffered from one predominant pain and be able to identify it
- •Patients who have stable analgesic medication during the study
- •Patients who understand and speak fluently French
- •Patients with health insurance
- •Patients who signed the written informed consent form
排除标准
- •Patients with severe depression according to Diagnostic and Statistical Manual (DSM) V criteria
- •Analgesic medication modified recently (less than 1month)
- •Patients with psycho-actives substances or alcohol abused
- •Patients with cognitive impairment (MoCA score < 25)
结局指标
主要结局
Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)
时间窗: 4 months
Develop and validate a French self-questionnaire to diagnose parkinsonian primary pain, this symptom questionnaire will be called 3PDQ for Primary Parkinsonian Pain Questionnaire. This questionnaire present 5 items: Location of the most embarrassing pain, Characteristics of pain, if the pain is associated in the same area with one or more of the symptoms, by what is the pain caused or increased, what criteria does the pain correspond to. It is sufficient for each item to check the corresponding boxes
次要结局
未报告次要终点