CBD for Musculoskeletal Pain
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to learn about the use of cannabidiol (CBD) capsules as a treatment for musculoskeletal pain. CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. The main questions it aims to answer are: Is CBD more effective than placebo at relieving pain for upper extremity musculoskeletal pain ? Is CBD safe for participants with upper extremity musculoskeletal pain? Participants will: take 4 weeks of daily CBD capsules take 4 weeks of daily placebo capsules answer surveys about how they are feeling and functioning. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Will I have to stop taking my current medications?
The trial requires participants to stop using certain medications, including those that are substrates of specific enzymes like CYP3A4, CYP2C19, CYP2C8, CYP2C9, CYP1A2, and CYP2B6, within 14 days before the study. Additionally, participants must not use opioids, topical analgesics, or any CBD products during the study.
What data supports the effectiveness of the drug Cannabidiol (CBD) for musculoskeletal pain?
Research suggests that CBD may help with chronic pain management, as seen in studies with fibromyalgia patients who reported improvements in pain and other symptoms. Additionally, CBD has shown potential in reducing pain behaviors in animal models and promoting tissue regeneration, which could be beneficial for musculoskeletal conditions.12345
Is CBD generally safe for humans?
Research shows that CBD is generally well-tolerated in humans, with most side effects being minor. However, some serious adverse reactions have been reported, especially when used with other medications like antiepileptics. It's important to discuss CBD use with a healthcare provider to ensure safety.12678
How does the drug CBD differ from other treatments for musculoskeletal pain?
CBD is unique because it is a natural compound from the cannabis plant that not only helps reduce pain and inflammation but also promotes tissue regeneration, which is not a common feature of other pain treatments. It is considered safe and well-tolerated, with no serious side effects reported.124910
Research Team
Brent DeGeorge, MD, PhD
Principal Investigator
University of Virginia Department of Plastic Surgery
Eligibility Criteria
This trial is for individuals experiencing upper extremity musculoskeletal pain, such as arm and muscle pain. Participants will take daily CBD capsules or placebo for 4 weeks each and complete surveys about their pain and function.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either CBD or placebo capsules twice daily for 4 weeks, followed by a crossover to the other condition for another 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Cannabidiol (CBD)
Cannabidiol (CBD) is already approved in United States, European Union for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
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Who Is Running the Clinical Trial?
Brent DeGeorge
Lead Sponsor
The Plastic Surgery Foundation
Collaborator