The Use of Cannabinoid Patch for Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT04412837|
Recruitment Status : Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis CBD Osteoarthritis||Drug: Topical CBD Patch Other: Placebo Patch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This will be a randomized double blinded parallel group clinical trial to determine safety and efficacy of 35mg CBD patch vs placebo patch in patients with knee osteoarthritis.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Patients, treating physician, and assessors will be blinded to study group.|
|Official Title:||The Use of Cannabinoid Patch for Knee Osteoarthritis|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: CBD Patch
Topical CBD patch to be worn for 24 hours and changed daily for the course of 4 weeks.
Drug: Topical CBD Patch
35 mg CBD patch
Placebo Comparator: Control Patch
Control placebo patch to be worn for 24 hours and changed daily for the course of 4 weeks.
Other: Placebo Patch
Identical patch without active ingredient.
- Influence of CBD patch on pain for patients with knee osteoarthritis using Visual Analogue Scale. [ Time Frame: 8 weeks. ]Efficacy of 35mg CBD Patch vs Placebo Patch on treatment of pain for patients with knee osteoarthritis assessed by a visual analogue scale using 0 as no pain and 10 as the worst pain. This will be collect at weeks 1, 2, 3, 4, and 8, where pain control method (CBD vs Placebo) is the between subjects' effect and week of treatment is the within subjects effect will be used to examine the association between pain control method and that outcome.
- Influence of CBD patch on physical and mental health for patients with knee osteoarthritis using the Short Form-12. [ Time Frame: 8 weeks. ]The Short Form-12 (SF-12) will be used to asses physical functioning, physical health problems, limitations, emotional problems and global mental health. Two summary scores, a mental component score (MCS-12) and a physical component score (PCS-12), are reported as difference compared to the population average, measured in standard deviations. Each increment of 10 points above or below 50, corresponds to one standard deviation away from the average. Increasing scores correspond to positive physical (maximum 56.6)/mental health (maximum 60.8), decreasing scores correspond to negative physical (minimum 24.0)/mental (minimum 19.1) health.
- Influence of CBD patch on quality of sleep for patients with knee osteoarthritis using the Pittsburgh Sleep Quality Index. [ Time Frame: 8 weeks. ]The Pittsburgh Sleep Quality Index (measures quality and patterns of sleep) will be given prior to enrollment, and at weeks 1,2,3,4,8. Measures seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme.
- Influence of CBD patch on physical function and emotional health for patients with knee osteoarthritis using the Brief Pain Inventory. [ Time Frame: 8 weeks. ]Physical function will be measured by the activity sub dimension of the reactive dimension of the Brief Pain Inventory (BPI) (total of the scores for walking, general activity, and work items) Emotional function will be measured by the affective sub dimension of the reactive dimension of the BPI (Total of the scores for relations with others, enjoyment of life, mood, and sleep), on a 0 to 10 scale, where 10 is the negative extreme.
- Influence of CBD patch on knee function and pain for patients with knee osteoarthritis using the Knee Injury and Osteoarthritis Outcome Score. [ Time Frame: 8 weeks. ]The Knee Injury and Osteoarthritis Outcome Score (KOOS) test will assess pain and function of the knee. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
- Safety Profile and Adverse Effects of CBD patch [ Time Frame: 8 weeks. ]
The safety of the CBD patch will be assessed by a 15 item questionnaire of the most commonly reported adverse events of cannabinoids in prior literature. Additional adverse reactions reported by patients or observed by the investigator will be noted and scored.
Scoring of the severity is based on a 0 to 3 interval scale (corresponding to none, mild, moderate, severe), whereby 3 reflects the negative extreme. The patients will be proactively assessed at 2, 4, and 8 weeks.
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): NCT04412837
|Contact: Nicholas Frane, DO||(763) firstname.lastname@example.org|
|Contact: Erik Stapleton, DO, MS||(813) email@example.com|
|United States, New York|
|Northwell Health Orthopedic Institute at Great Neck|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator: Vijay Rasquinha, MD|
|Principal Investigator:||Vijay Rasquinha, MD||Northwell Health|
|Study Director:||Robert Duarte, MD||Northwell Health|