Effect of Topical CBD Cream for Degenerative Hallux Disorders

• Status: Active, not recruiting
• Trial end date: 2022-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborators: Mid-America Orthopaedic Association; Mid-America Orthopaedic Association (MAOA)
• Treatments: Epidiolex

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• A previous operative procedure to the first metatarsal for treatment of hallux valgus or hallux rigidus

• VAS pain score at presentation less than 4

• Concomitant hallux valgus and hallux rigidus on the ipsilateral side

• Allergy to CBD, Cannabidiolic acid (CBDa) or any other ingredient contained in the topical cream

• Pregnant patients