Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of Cannabinoid Patch for Knee Osteoarthritis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412837
Recruitment Status : Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Solace Brands, Inc.
Information provided by (Responsible Party):
Northwell Health

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis CBD Osteoarthritis Drug: Topical CBD Patch Other: Placebo Patch Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age>18 years old
  2. Osteoarthritis diagnosed radiographically as Kellgren Lawrence classification 2-4
  3. Visual analogue scale greater than 3 but less than 9
  4. Subject is able to provide written informed consent prior to any study procedures or interventions.
  5. 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.
  6. Able to wear a patch for 24 hours a day
  7. Able to participate in physical therapy

Exclusion Criteria:

  1. Subject presents with a visual analogue scale score less than 4 or greater than 8.
  2. Subject is Pregnant.
  3. 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.
  4. Subject has had prior surgery to the studied lower extremity within 6 months.
  5. Subject has a known history of allergy to CBD or its derivatives
  6. Subject has a known history of allergic, idiosyncratic, or serious adverse reactions to acetaminophen.
  7. Patient had recent steroid injection to the studied knee within the last 3 months
  8. Subject has an inability to be available for follow up
  9. 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.
  10. 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.
  11. Patient has chronic opioid dependency (taking opioid's >3months), currently taking selective serotonin reuptake inhibitor or benzodiazepines.
  12. Patient currently using CBD product and not willing to discontinue use 1 week prior to enrollment.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Nicholas Frane, DO (763) 439-5741 nicholasfrane@gmail.com
Contact: Erik Stapleton, DO, MS (813) 220-6777 erik.stapleton1@gmail.com

Locations
Layout table for location information
United States, New York
Northwell Health Orthopedic Institute at Great Neck
New Hyde Park, New York, United States, 11040
Principal Investigator: Vijay Rasquinha, MD         
Sponsors and Collaborators
Northwell Health
Solace Brands, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Vijay Rasquinha, MD Northwell Health
Study Director: Robert Duarte, MD Northwell Health
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04412837    
Other Study ID Numbers: 20-0048
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northwell Health:
Cannabidiol
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases