ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
研究概览
简要总结
The aim of this observational study is to evaluate the effects of cannabis extract Avextra 10/10 solution on pain, fatigue, sleep, and quality of life among patients affected by fibromyalgia (FM) syndrome. The main question it aims to answer is:
Does cannabis extract have a positive effect on pain after 12 weeks in these patients?
Participants diagnosed from FM will be evaluated and will fill survey about their pain, fatigue, sleep, anxiety, depression and quality of life at baseline, 4 weeks, 8 weeks and 12 weeks after the initiation of cannabis extract Avextra 10/10 solution.
详细描述
Fibromyalgia (FM) is a chronic condition characterized by widespread pain, mechanical hyperalgesia, fatigue, sleep disturbances, psychological and cognitive impairments, mood changes, headaches, migraines, and gastrointestinal symptoms. Despite its recognition as a medical condition with diagnostic criteria and severity scales, its exact causes and effective treatment remain unclear. FM significantly impacts patients' quality of life and poses a societal burden due to high direct and indirect costs.
Cannabis-based treatments have gained attention for FM symptom management. In Italy, therapeutic cannabis has been legal since 2013 and may be prescribed when conventional treatments fail or cause intolerable side effects. Its primary components, tetrahydrocannabinol (THC) and cannabidiol (CBD), interact with cannabinoid receptors to potentially provide pain relief, anti-inflammatory effects, and mood stabilization.
The study aims to evaluate the efficacy of the standardized cannabis extract Avextra 10/10 (10 mg/mL THC and 10 mg/mL CBD) for FM treatment.
Objectives Primary objective: -Assess the extract's impact on pain after 12 weeks.
Secondary objective:
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
- •Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria.
- •Patients with FM prescribed cannabis extract Avextra 10/10 solution after failure and/or intolerance of first- or second-line treatment.
- •Aged 18 years and older.
- •Able to fully understand and fill questionnaires.
- •Able to provide informed consent, according to requirements of local IRB/ethics committee.
排除标准
- •Known history of pain not due to FM.
- •Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks.
- •Patients who are taking other types of medical cannabis besides Avextra 10/10 solution.
- •Concomitant diagnosis of other pathologies that could interfere with clinical judgment.
- •Psychiatric diagnosis according to DSM-V-TR
- •Pregnancy or breastfeeding
结局指标
主要结局
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
时间窗: 12 weeks
The primary endpoint is based on a comparative analysis between the Visual Analogic Scale (VAS) score reported before cannabis extract Avextra 10/10 solution and after 12 weeks of therapy. VAS will use a 100 mm pain line where 0 represents "no pain at all" and 100 is "maximum pain ever experienced".
次要结局
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on sleep quality among patients affected by FM using Pittsburgh sleep quality index (PSQI)(4, 8 and 12 weeks)
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain using Widespread pain indexWPI(4, 8 and 12 weeks)
- Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life using The Italian versions of the Revised Fibromyalgia Impact Questionnaire (FIQR)(4, 8 and 12 weeks)
- Describe any adverse events or the principal reasons of drug discontinuation.(4,8,12 weeks)
- 1. Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM(4, 8 weeks)
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Functional Appreciation Scale (FAS)(4, 8, 12 weeks)
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Symptom Severity Scale (SSS)(4, 8, 12 weeks)