Assessment of the Prevalence of Analgesics Opioid Misuse in Chronic Non-cancer Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 951
- 试验地点
- 1
- 主要终点
- Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale
研究概览
简要总结
Chronic pain is a worldwide health problem due to its high prevalence and its difficult management with a significant impact on quality of life. Pain and addiction co-occur frequently. Indeed, the prevalence of addiction in patients with chronic non-cancer pain may affect from 0% to 50% of patients (Højsted et al 2010). This large variability in the estimation of addiction prevalence in chronic non-cancer pain patients is at least partly due to a lack of standardization of the selected patients from the clinical or therapeutic point of view and the lack of consensus in the use of a specific evaluation tool or gold standard. Indeed, several tools are currently available at the international level with varying efficiencies and precisions (Chou et al 2009, Turk, Swanson, and Gatchel 2008, Højsted and Sjøgren 2007). In France, no data are available on the prevalence of analgesic opioid misuse in chronic non-cancer pain patients, due to the lack clinical studies and validated tools in French.
详细描述
This is an observational study . Each addictovigilance centre will contact Pain Clinics in order to enroll patients meeting the inclusion criteria. The questionnaires will be prepared and sent to the participating centres by the coordinating centre (Clermont-Ferrand). Participation in the study will be systematically proposed by the physician during the study inclusion period (3 months). Patients meeting all inclusion criteria will be enrolled after receiving oral information about the study.
This questionnaire can be semi-directed (doctor / nurse / CRA) and will be carried out during a consultation as part of their usual care. Answering the questionnaire should take no more than 10 minutes. No additional diagnostic or monitoring procedures will be applied to patients.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male or female) ≥ 18 years old
- •Patients with chronic non-cancer pain for at least 6 months
- •Patients treated with analgesic opioids for at least 3 months
排除标准
- •Patients (male or female) < 18 years old
- •Patients with chronic pain for less than 6 months
- •Patients with cancer pain
- •Patients treated with analgesic opioids for less than 3 months
结局指标
主要结局
Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale
时间窗: at day 1
A score ≥ 2 is considered positive and will define a misuse behavior
次要结局
- Analgesic opioids used by the patient will be collected in the questionnaire(at day 1)
- Patients' profiles and associated risk factors of opioid misuse will be described through socio-demographic contained in the questionnaire(at day 1)