CBD Knee Osteoarthritis Study

Knee Pain

The investigators will use ecological momentary assessment to collect knee pain scores and develop pain trajectories. A Visual Analog Scale of Self-Reported Pain will be assessed at study visits and up to once a day via text message using the Wong-Baker visual analogue scale. A score of 0 is no pain and a score of 10 is severe pain. Please note this is crossover clinical trial and there are 2 Baseline Visits (One and Two). Knee Pain will be assessed at the Screening Visit as an eligibility criteria and at Baseline One Visit (Day 1), Follow-up One Visit (Day 30), Baseline Two Visit (Day 44), and Follow-up Two Visit (Day 74). The Baseline One Visit will occur 2 weeks after the Screening Visit. Change in knee pain scores on the Visual Analog Scale of Self-Reported Pain will be assessed from the Baseline One Visit to the the Follow-up One Visit and from the Baseline Two Visit to the the Follow-up Two Visit.

Sleep

The PROMIS (Patient-Reported Outcomes Information System) Sleep Questionnaire will be used to assess sleep disturbance and sleep related impairment over the past 7 days. The questionnaire is divided into two distinct short-form assessments: 1) PROMIS Sleep Disturbance and 2) PROMIS Sleep-Related Impairment. The PROMIS sleep questionnaire utilizes a standardized T-score metric where the general U.S. population average is 50, with a standard deviation of 10. Higher scores indicate a greater severity of the concept being measured (e.g., more sleep disturbance or more sleep-related impairment). Below 55 is within normal limits, 55-59.9 is mild, 60-69.9 is moderate, and 70 and above is severe. Please note this is crossover clinical trial and there are 2 Baseline Visits (One and Two). Sleep will be assessed at the Baseline One Visit (Day 1), Follow-up One Visit (Day 30), Baseline Two Visit (Day 44), and Follow-up Two Visit (Day 74).

Knee Related Quality of Life and Function

The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used to assess five knee dimensions: pain, symptoms, activities of daily living (ADL), sport and recreation function, and knee-related quality of life. Each dimension is scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems. Please note this is crossover clinical trial and there are 2 Baseline Visits (One and Two). Knee Related Quality of Life and Function as measured by the KOOS questionnaire will be assessed at the Baseline One Visit (Day 1), Follow-up One Visit (Day 30), Baseline Two Visit (Day 44), and Follow-up Two Visit (Day 74). The Baseline One Visit will occur 2 weeks after the Screening Visit. The Follow-up One Visit will occur 1 month after the Baseline One Visit. The Baseline Two Visit will occur 2 weeks after the Follow-up One Visit. The Follow-up Two Visit will occur 1 month after the Baseline Two Visit.

Adherence with Study Medication

The investigators will measure adherence with study medication by weighing the study medication bottles at study visits to determine the number of dosage units used from the bottle during medication periods. This weighing method has been used to assess adherence in other topical medication trials. Please note this is crossover clinical trial and there are 2 Baseline Visits (One and Two). Bottle weighing to measure adherence with study medication will be assessed at the Baseline One Visit (Day 1), Follow-up One Visit (Day 30), Baseline Two Visit (Day 44), and Follow-up Two Visit (Day 74). The number of dose units used from the Baseline One Visit to the the Follow-up One Visit will be assessed and the number of dose units used from the Baseline Two Visit to the the Follow-up Two Visit will be assessed.

Adherence with Study Medication by Self-report

The investigators will also assess adherence with study medication by self-report via text message during medication use weeks up to 60 times between the Baseline One Visit (Day 1) and Follow-up Two Visit (Day 74). The investigators will use a simple question to ask the participant whether the study oil was placed on the Right Knee (Yes/No) and the Left Knee (Yes/No) today. This measure will be used to encourage compliance with the Study Intervention.