Effect of Topical CBD Cream for Degenerative Hallux Disorders

Rush

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Hallux Rigidus; Hallux Valgus

Treatments: Drug: Placebo cream; Drug: magnesium-cannabidiolic acid cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04103814

19052902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Mg-CBDa cream

Active Comparator group

Description:

Subjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus.

Treatment:

Drug: magnesium-cannabidiolic acid cream

Placebo cream

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo cream