Effect of Topical CBD Cream for Degenerative Hallux Disorders

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

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.

Study Overview

• Status: Terminated
• Conditions: Hallux Valgus; Hallux Rigidus
• Intervention / Treatment: Drug: magnesium-cannabidiolic acid cream; Drug: Placebo cream

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Midwest Orthopaedics at Rush

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: magnesium-cannabidiolic acid cream; Patients will receive Mg-CBDa (magnesium-cannabidiolic acid) cream for topical treatment of hallux rigidus or hallux valgus.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly Foot Function Index	The foot function index (FFI) is a questionnaire that measures foot pain and disability. It is self-administered and consists of 23 items divided into 3 subscales (pain, disability, and activity limitation). The pain subcategory consists of 9 questions (scored out of 90) and is a measure of pain in different situations, such as walking with shoes versus barefoot. The disability subcategory consists of 9 questions (scored out of 90) and measures functional activities, such as difficulty walking upstairs. The activity limitation subcategory consists of 5 questions (scored out of 50) and measures limitations caused by the foot problem. All three subcategories are summed together to get a final number, with higher numbers indicating worse pain.	4 weeks
Post-treatment VAS Score Averaged Daily Over 4 Weeks.	Weekly visual analog system (VAS) pain scores will be measured daily for four weeks. The VAS pain score is a measure of pain severity. It is measured on a scale from 0 to 10, with 10 being the worst pain the patient has experienced. No patients completed full enrollment so no data was analyzed.	4 weeks

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Mid-America Orthopaedic Association (MAOA)
• Investigators: Principal Investigator: Simon Lee, MD, Midwest Orthopaedics at Rush

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2019
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Hallux Valgus; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: 19052902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes