An Open-Label, Prospective, Observational Study to Assess the Response to Cannabidiol (CBD) Oil in Subjects With Chronic Mechanical Back Pain (MBP)
试验速览
- 阶段
- 不适用
- 发起方
- perceiveMD
- 入组人数
- 52
- 主要终点
- To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil
研究概览
简要总结
This study is a 12-week open-label, prospective, observational study to assess how subjects with chronic mechanical back pain respond to cannabidiol (CBD)
详细描述
Purpose: To Assess the Response to Cannabidiol (CBD) Oil in Subjects with Chronic Mechanical Back Pain (MBP)
Hypothesis: Cannabis use provides many patients with significant low back pain relief.
Justification: Mechanical back pain is a condition affecting around 30% of the general adult population. It is the second most common reason to see a family physician and the most common reason patients end up on work disability. Long term chronic pain is associated with mood and anxiety disorders in a lot of patients, which suggests that a successful plan for the treatment of chronic pain must also consider the treatment of possible co-existing psychiatrist conditions.
Objectives:
To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to communicate well with the Investigator(s), understand and comply with the requirements of the study, and provide written consent
- •Age ≥21 years
- •Diagnosed with MBP with symptom onset >3 months prior to screening visit
- •Must have pain severity ≥4/10 on VAS for at least 3 months as reported by the patient
- •Decided to take CBD oil for the treatment of MBP
- •Must have access to a computer or laptop and be able to operate the required video conference platform
排除标准
- •Cause of pain due to malignancy, infection, fracture, or spondylarthritis
- •Recent (within the last 3 months) spinal trauma
- •Leg dominant/radicular pain
- •Current active fibromyalgia
- •Female who is pregnant, nursing, or plan to become pregnant during the study
- •Allergies to CBD or any components of the CBD oil to be used in the study
- •Active significant medical and/or psychological illness which, in the opinion of the Investigator,
- •is not suitable to participate in the study (e.g. malignancy, hepatic disease, CAD, COPD, schizophrenia, etc.)
- •Changes in doses of baseline analgesics such as acetaminophen, pregabalin, gabapentin, opioids, or glucocorticoids within 1 month prior to the study
结局指标
主要结局
To assess the change in pain measured by 0 to 10 point visual analogue scale (VAS) for patients with chronic mechanical back pain treated with CBD oil
时间窗: 12 weeks
52 patients with pain severity ≥4/10 on Visual Analog Scale (VAS) for at least 3 months who have decided to take CBD oil (up to 50 mg SL BID) to manage their symptoms will be recruited to participate. As per standard of care, patients will be encouraged to keep baseline doses of analgesics (if any) stable for the first 6 weeks of the study to monitor their response to CBD oil. Analgesic medications will be allowed to be adjusted between weeks 6 to 12.
次要结局
未报告次要终点