Status:
WITHDRAWN
The Use of Cannabinoid Patch for Knee Osteoarthritis
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Solace Brands, Inc.
Conditions:
Knee Osteoarthritis
CBD
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized, double-blind 2-arm parallel group study to determine the efficacy of a cannabinoid (CBD) patch on reducing pain in patients with knee osteoarthritis.
Detailed Description
The aim of this study is to determine the efficacy of cannabinoid (CBD) patch on reducing pain and improving functional status in patients with knee osteoarthritis (OA). The investigators hypothesize ...
Eligibility Criteria
Inclusion
- Age\>18 years old
- Osteoarthritis diagnosed radiographically as Kellgren Lawrence classification 2-4
- Visual analogue scale greater than 3 but less than 9
- Subject is able to provide written informed consent prior to any study procedures or interventions.
- Ability, in the opinion of the investigator, to understand the nature of the study and comply with protocol requirements including compliance with scheduled visits, treatment plan, and any other study procedures outlined in this protocol.
- Able to wear a patch for 24 hours a day
- Able to participate in physical therapy
Exclusion
- Subject presents with a visual analogue scale score less than 4 or greater than 8.
- Subject is Pregnant.
- Patient has known recent substance abuse or dependence on alcohol (regularly consumes 3 or more alcoholic drinks per day), narcotic analgesics, tranquilizers, or opioids; in the judgement of the investigator within the past 3 years.
- Subject has had prior surgery to the studied lower extremity within 6 months.
- Subject has a known history of allergy to CBD or its derivatives
- Subject has a known history of allergic, idiosyncratic, or serious adverse reactions to acetaminophen.
- Patient had recent steroid injection to the studied knee within the last 3 months
- Subject has an inability to be available for follow up
- Any patients with prior liver pathology including, cirrhosis, hepatitis, Hepatic Carcinoma, or elevated liver function tests will be excluded from the study group. Patients with elevated baseline transaminase levels above 3 times the upper limit of normal, accompanied by elevations in bilirubin above 2 times the upper limits of normal.
- Subjects with a medical disorder, condition or history such that could impair the subject's ability to participate or complete this study in the opinion of the investigator.
- Patient has chronic opioid dependency (taking opioid's \>3months), currently taking selective serotonin reuptake inhibitor or benzodiazepines.
- Patient currently using CBD product and not willing to discontinue use 1 week prior to enrollment.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04412837
Start Date
October 1 2022
End Date
February 1 2024
Last Update
January 19 2023
Active Locations (1)
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1
Northwell Health Orthopedic Institute at Great Neck
New Hyde Park, New York, United States, 11040