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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04103814|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2019
Last Update Posted : May 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hallux Valgus Hallux Rigidus||Drug: magnesium-cannabidiolic acid cream Drug: Placebo cream||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial|
|Actual Study Start Date :||October 20, 2019|
|Estimated Primary Completion Date :||June 20, 2022|
|Estimated Study Completion Date :||November 20, 2022|
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.
- 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.
- 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.
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
|United States, Illinois|
|Midwest Orthopaedics at Rush|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Simon Lee, MD||Midwest Orthopaedics at Rush|