NCT04726579

CBD Oil in Mechanical Back Pain

An Open-Label, Prospective, Observational Study to Assess the Response to Cannabidiol (CBD) Oil in Subjects With Chronic Mechanical Back Pain (MBP)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 52 (estimated)
• Sponsor: perceiveMD · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is a 12-week open-label, prospective, observational study to assess how subjects with chronic mechanical back pain respond to cannabidiol (CBD)

Detailed description

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 Research Design: 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. Enrolled patients will be assessed at baseline, week 6, and week 12 for a total of 3 virtual visits. Patients will be asked to fill out online questionnaires and a medication diary to assess effectiveness and compliance. Safety will also be assessed throughout the study. Patients will be asked to report any adverse events (AEs) at study completion or earlier if they decide to withdraw. In addition, they will be provided a phone number to PerceiveMD where they can report any serious adverse events (SAEs) in between scheduled visits. Patients will be instructed to report any SAEs within 24 hours. PerceiveMD will then communicate this to one of the Investigators the same day. All adverse reactions will be recorded in the study electronic medical record (EMR), InputHealth. Statistical Analysis: The primary analysis will be measured in all enrolled patients who are dispensed drug. Patient data will be collected using online electronic questionnaires generated through InputHealth and stored within InputHealth. Patient data will additionally be collected at the time of their virtual visits with the Investigator(s) at PerceiveMD. This data will be recorded and stored within InputHealth. For descriptive summaries, the mean, sample size (n), standard deviation (SD), standard error (SE), median, minimum (min), and maximum (max) will be calculated for continuous variables. For categorical variables, frequency and percentage in each category will be provided. Change from baseline value will be calculated at each visit. No imputation will be made for missing values. Pain VAS, modified Oswestry Low Back Pain Disability, and GAD7 will be compared between groups, with mean values and 95% confidence interval provided. Percentage of patients with 30% and 50% improvement in pain VAS will also be assessed. Change in analgesic medication dose and use will be analyzed and reported. Based on the extent of missing data, additional analyses may be conducted (e.g. last observation carried forward (LOCF), non-responder index) as a sensitivity analysis to support the primary analysis

Conditions

• Mechanical Low Back Pain

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-01-27
• Last updated: 2021-01-27