The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change from baseline on the S-TOPS pain symptom scale
研究概览
简要总结
The objective of the current study is to prospectively assess the effect of cannabis on pain and functional outcomes in a large group of patients with chronic pain.
详细描述
This is a prospective, observational, open-label study carried out at the ambulatory pain clinic of Hadassah-Hebrew University Medical Center Pain Relief Unit.
Study population: Patients suffering from chronic pain that has not been relieved with other analgesic medications, who are eligible for treatment with medical cannabis (cigarettes, oil or cookies) following approval of Israeli Ministry of health.The patients will receive a prescription to be dispensed at pre-approved cannabis distribution points by a certified provider.
In this study, the efficacy of the cannabis treatment on pain and related quality of life (QoL) outcomes will be assessed by administering the S-TOPS questionnaire (Haroutiunian, Pain 2012), and the Brief Pain Inventory (BPI) before the treatment (baseline), and on expected follow-up visits at approximately 6 and 12 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Chronic pain, with duration of 3 months or longer
- •Lack of satisfactory analgesic response or intolerable adverse effects with at least two analgesics from 2 different drug classes at full dose.
排除标准
- •Inability to read and understand the informed consent form.
- •History of drug abuse/dependence
- •Psychiatric co morbidity (or history) of schizophrenia or acute psychosis.
- •Family history of schizophrenia.
- •Psychologist evaluation of high abuse risk.
结局指标
主要结局
Change from baseline on the S-TOPS pain symptom scale
时间窗: 1 year
The primary outcome is pain reduction (change from baseline) assessed by the Pain Symptom scale of the S-TOPS instrument
次要结局
- Change from baseline on S-TOPS emotional/social disability scales(6 and 12 months)
- Change from baseline on S-TOPS satisfaction scales(6 and 12 months)
- Change from baseline on SLP9 sleep disability scale(6 and 12 months)
- Change from baseline on BPI severity/interference scales(6 and 12 months)
- Change from baseline on S-TOPS physical disability scales(6 and 12 months)
研究者
Elyad Davidson
MD
Hadassah Medical Organization