1,937
Participants
Start Date
February 1, 2021
Primary Completion Date
April 8, 2025
Study Completion Date
April 8, 2025
Duloxetine
Duloxetine is a drug that is used to improve pain and function in people with knee osteoarthritis (KOA). Duloxetine is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety disorder, fibromyalgia, and joint pain. It will be titrated up from 20 or 30mg according to a schedule provided by a study provider.
Intra-Articular Injection
Intra-Articular Injection is an injection of 3-6 milliliter (mL) hyaluronic acid (HA) mixed with 1 milliliter (mL) depo methylprednisolone (a steroid) and 2 mL 0.5% bupivacaine (an anesthetic) into the knee.
Nerve Procedure with long acting blocks
People assigned to receive this will have 1 milliliter (mL) of a long-acting local anesthetic (a.k.a. liposomal bupivacaine or EXPAREL) and steroid injected into the knee.
Nerve Procedure with nerve ablation
People assigned to receive this will have heat applied to destroy the nerve signaling pain in the knee. Steroid will be administered after the procedure to reduce the risk of neuritis.
Pain Coping Skills Training
Participants will be provided with a written manual that includes login information for the pain coping skills training website. The participants will be expected to log into the system weekly, work through the modules, and participate in skills practice. This intervention will be conducted in combination with best practices and duloxetine.
Best Practices
Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments.
Weill Cornell University, New York
University of Rochester Medical Center, Rochester
Walter Reed Army Medical Center, Bethesda
Johns Hopkins, Baltimore
University of Virginia, Charlottesville
Wake Forest University, Winston-Salem
University of North Carolina, Chapel Hill
Atlanta VA Medical Center, Decatur
Emory University, Atlanta
University of Florida, Gainesville
Vanderbilt University, Nashville
Cleveland VA Medical Center, Cleveland
University Hospitals, Cleveland
University of Iowa, Iowa City
University of Minnesota, Minneapolis
Northwestern University, Chicago
University of Colorado, Aurora
University of Utah, Salt Lake City
University of California San Diego, San Diego
VA Medical Center San Diego, San Diego
University of California Davis, Sacramento
Oregon Health and Science University, Portland
University of Washington, Seattle
Brigham and Women's Hospital, Boston
Collaborators (1)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Pacira Pharmaceuticals, Inc
INDUSTRY
Johns Hopkins University
OTHER