The Use of Cannabinoid Patch for Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title: The Use of Cannabinoid Patch for Knee Osteoarthritis

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 that the use of CBD patch will provide superior pain relief to placebo patch. This will be a randomized, double-blind 2-arm parallel group study in 74 male and female subjects with pain from knee osteoarthritis. Site staff will document the patient's prior treatment for knee osteoarthritis and once the diagnosis has been made, they will be offered to enroll in the study.

After randomization, patients will either be prescribed CBD patch to be used topically for diagnosed knee osteoarthritis versus placebo patch. It will be performed at one site, the physician's office. The study coordinator will be in charge of keeping track of the different patches and all other study personnel and patients will be blinded to the treatment arm. The statistician will conduct the randomization. He will be unblinded and assign participant numbers.

Patients will be diagnosed in an office setting for knee osteoarthritis based on radiographs using the Kellgren Lawrence classification. It is the standard of care to obtain orthogonal knee radiographs when evaluating a patient for knee pain. This will be considered when assessing if the patient is eligible to participate given their pathology. This can be a new diagnosis or an already established diagnosis. The previous treatments that they have received will be noted in the patient charts while screened for eligibility.

Patients taking opioids only recently (less than 3 months) will be required to halt treatment at the time of study enrollment. Opioids don't have anti inflammatory properties so a washout period is not necessary. General patient demographics will be collected using the electronic medical record including: Age, Sex, BMI, Radiographic Osteoarthritis scale (Kellgren Lawrence), which will be put into database by the study investigators and co investigators.

Consent will be obtained by study personnel in the clinical office setting after meeting all study criteria and diagnosis of knee osteoarthritis based on exam and knee xrays. All patients diagnosed with knee osteoarthritis, and who are enrolled in the study, will be prescribed physical therapy that focuses on non-operative treatment such as low impact exercises and activity modification. The patients will not medicate with anti-inflammatory while enrolled in the study. Administration will follow a model of topical patch application which will consist of either the formulated CBD patch (35mg) or identical placebo patch. This patch will be applied to the arthritic knee directly central on the knee. In the event of patients with a diagnosis of bilateral knee OA, the patch will be placed on the knee that has visual analogue scale (VAS) >3 but <9. This patch will be placed daily for 24 hours and replaced each day. Including the initial enrollment visit, the patient will meet with the diagnosing orthopedic surgeon at various time points, and will also have remote check ins by study personnel to assess for adverse events and any issues they are having at 2, 4, and 8 weeks. The patient will have the patch for the first 4 weeks of the study followed by 4 weeks without patch which will conclude their participation at 8 weeks. The patients will all begin physical therapy as part of their routine clinical care within 1 week of beginning the study. During this time the patient will be distributed various surveys to measure patient outcomes. The investigators will be looking at pain as a primary endpoint using visual analogue scale with a 2 point difference deemed the minimal clinically important difference.

Subjects who are randomized to either group who have uncontrolled pain will be instructed to take a rescue medication, acetaminophen over the counter use Q 6 hours as needed will be allowed and recorded in a daily drug use diary which will be provided to them.

The patients will have contact information of the surgeon and residents to contact if any side effects are encountered. Compliance with patch use/application, side effects and adherence to physical therapy will also be recorded. Software with be used for both data collection and survey administration for confidential participation, which is a user-friendly HIPAA compliant service utilized by our health system. If the patient is unable to respond to the surveys via their phone app then hard copies of the survey will be given to them and collected by the investigator. ;

Related Conditions & MeSH terms

• CBD
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT04412837
• Study type: Interventional
• Source: Northwell Health
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2022
• Completion date: February 2024