Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial
Who is this study for? Patients with hallux disorders
What treatments are being studied? Magnesium+Cannabidiolic acid cream
Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with a new diagnosis of hallux rigidus or hallux valgus
• VAS pain score of 4 or higher
• Age \> 18 years
• The patient provides informed consent
Locations
United States
Illinois
Midwest Orthopaedics at Rush
Chicago
Time Frame
Start Date: 2019-10-20
Completion Date: 2023-05-15
Participants
Target number of participants: 11
Treatments
Active_comparator: Mg-CBDa cream
Subjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus.
Placebo_comparator: Placebo cream
Subjects in this group will receive the inactive CBD cream for topical treatment of hallux valgus or hallux rigidus. The ingredients of the placebo cream are: butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), and food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.
Authors
Sponsors
Collaborators: Mid-America Orthopaedic Association
Leads: Rush University Medical Center