Clinical trial NCT04103814: Effect of Topical CBD Cream for Degenerative Hallux Disorders
Official title: Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hallux Valgus
Hallux Rigidus
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Mid-America Orthopaedic Association
First posted: 2019-09-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled patients will receive either active Mg-CBDa (magnesium-cannabidiolic acid) cream or placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus.
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Post-treatment VAS Score Averaged Daily Over 4 Weeks.
timeFrame: 4 weeks
measure: Weekly Foot Function Index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
Study officials:
affiliation: Midwest Orthopaedics at Rush
name: Simon Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: