Observational Study of Cannabis Extract Avextra 1010 for Treating Fibromyalgia Syndrome Assessing Pain and Quality of Life Over 12 Weeks

What this Trial Is About

This research aims to evaluate the effects of the cannabis extract Avextra 1010 solution on symptoms such as pain, fatigue, sleep, anxiety, depression, and quality of life in patients diagnosed with fibromyalgia FM syndrome. FM is a chronic condition causing widespread pain, fatigue, sleep disturbances, mood changes, and other symptoms, significantly impacting patients quality of life. The study focuses on whether this cannabis extract can improve pain after 12 weeks of use. Participants prescribed the cannabis extract Avextra 1010 solution, which contains 10 mgmL THC and 10 mgmL CBD, will be observed over 12 weeks. The study is observational, with patients continuing their routine clinical care. Data will be collected at baseline and at 4, 8, and 12 weeks after starting the cannabis extract treatment to assess effects on pain and other symptoms. Follow-up visits occur at 15, 30, 60, 90 days, and 6 months after starting treatment. During the study, participants will complete surveys assessing pain, fatigue, sleep quality, anxiety, depression, and quality of life at scheduled intervals. Clinical assessments will also gather information about tender points, smoking status, physical activity, medication use, and any side effects or reasons for stopping the cannabis extract. The primary outcome is the change in pain after 12 weeks. Researchers will monitor safety and treatment effects throughout the study period.

Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study