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Effect of Topical CBD Cream for Degenerative Hallux Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103814
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Mid-America Orthopaedic Association
Information provided by (Responsible Party):
Kamran S Hamid, MD, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Hallux Rigidus Drug: Cannabidiol cream Drug: Placebo cream Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Enrolled patients will receive either active chylobinoid cream or placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial
Estimated Study Start Date : October 20, 2019
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CBD cream
Subjects in this group will receive the active CBD cream for topical treatment of hallux valgus or hallux rigidus.
Drug: Cannabidiol cream
Patients will receive cannabidiol 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.




Primary Outcome Measures :
  1. Post-treatment VAS score averaged daily over 4 weeks. [ Time Frame: 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.

  2. Weekly Foot Function Index [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103814


Contacts
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Contact: Kamran S Hamid, MD, MPH 312-432-2304 foot.research@rushortho.com
Contact: Daniel D Bohl, MD, MPH 414-640-7245 danielbohl@gmail.com

Sponsors and Collaborators
Rush University Medical Center
Mid-America Orthopaedic Association
Investigators
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Principal Investigator: Kamran S Hamid, MD, MPH Midwest Orthopaedics at Rush

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Responsible Party: Kamran S Hamid, MD, Orthopaedic Surgeon, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04103814    
Other Study ID Numbers: 19052902
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hallux Valgus
Hallux Rigidus
Hallux Limitus
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries
Epidiolex
Anticonvulsants