NCT04103814

Effect of Topical CBD Cream for Degenerative Hallux Disorders

Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. While operative interventions exist, nonoperative modalities are the mainstay of treatment for most patients. Options include shoe wear modification, manual and physical therapy, intraarticular injection of corticosteroids or sodium hyaluronate, oral nonsteroidal anti-inflammatories, and foot orthoses. Oral anti-inflammatories are the most effective non-operative strategy, but unfortunately, are associated with major adverse side effects and are contraindicated in many patients. 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. This prospective randomized trial will compare topical CBD cream vs placebo cream for the treatment of pain secondary to hallux valgus and hallux rigidus. The primary outcome of interest in the change in pre and post-treatment Visual Analog System (VAS) pain scores. VAS pain score is a measurement on a continuum of values of pain intensity. 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.

Conditions

• Hallux Valgus
• Hallux Rigidus

Interventions

Type	Name	Description
DRUG	magnesium-cannabidiolic acid cream	Patients will receive Mg-CBDa (magnesium-cannabidiolic acid) cream for topical treatment of hallux rigidus or hallux valgus.
DRUG	Placebo cream	Patients will receive placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus. The ingredients of the placebo cream are as follows: Butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.

Timeline

• Start date: 2019-10-20
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2019-09-25
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study