1. Impact of an acute 1-month cannabidiol treatment on pain and inflammation after a long bone fracture: a triple-blind randomised, placebo-controlled, clinical trial protocol.
- Author
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Brazeau D, Deshaies AA, Williamson D, Bernard F, Arbour C, Pinard AM, Rouleau D, and De Beaumont L
- Subjects
- Humans, Adult, Middle Aged, Inflammation drug therapy, Male, Young Adult, Aged, Female, Randomized Controlled Trials as Topic, Adolescent, Pain Measurement, Analgesics therapeutic use, Analgesics administration & dosage, Acute Pain drug therapy, Acute Pain etiology, Cannabidiol administration & dosage, Cannabidiol therapeutic use, Fractures, Bone
- Abstract
Introduction: Acute pain levels following orthopaedic injury (eg, fracture) are a predictor of the onset of chronic pain, which affects nearly 50% of fracture patients and impairs functional recovery. Among current pharmacological treatments for acute pain, non-steroidal anti-inflammatory drugs have been associated with delayed bone healing, while opioids inhibit effective bone remodelling, increase the risk of pseudarthrosis and carry a high risk of addiction. In light of this, the development of new pain treatments is essential. Cannabidiol (CBD), a non-addictive and non-psychotropic cannabis component stands out as a potential therapeutic agent, given its analgesic and anti-inflammatory properties as well as its potential benefits for bone healing. This randomised controlled trial aims to investigate the effect of acute CBD treatment, compared with placebo, on patients' self-reported pain, inflammation and well-being following a fracture injury., Methods and Analysis: This is a triple-blind, randomised, placebo-controlled clinical trial. A total of 225 adults aged 18-70 years, who have suffered a long bone fracture and were treated at the Hôpital du Sacré-Coeur de Montréal, will be randomly assigned within 1 week to one of three treatment arms (25 mg or 50 mg of CBD or placebo) for 1 month. The primary outcome will be the difference in the pain score between groups at 1-month follow-up. Secondary outcomes will include measures of persistent pain, inflammation, opioid usage, quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function. Data will be collected at baseline, 1-month and 3-month follow-ups., Ethics and Dissemination: This study obtained a Health Canada licence for use of cannabis products. It has also been approved by Health Canada and the Research Ethics Board of the CIUSSS du Nord-de-l'Île-de-Montréal (Project ID 2025-2105). The findings will be published in a peer-reviewed journal and presented at local, national and international conferences. The trial's results will be made publicly available on the ClinicalTrials.gov database., Trial Registration Number: NCT06448923., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)
- Published
- 2025
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