A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

1,937

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

April 8, 2025

Study Completion Date

April 8, 2025

Conditions
Knee Osteoarthritis
Interventions
DRUG

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.

COMBINATION_PRODUCT

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.

PROCEDURE

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.

PROCEDURE

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.

BEHAVIORAL

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.

OTHER

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.

Trial Locations (24)

10019

Weill Cornell University, New York

14623

University of Rochester Medical Center, Rochester

20889

Walter Reed Army Medical Center, Bethesda

21287

Johns Hopkins, Baltimore

22908

University of Virginia, Charlottesville

27517

Wake Forest University, Winston-Salem

27599

University of North Carolina, Chapel Hill

30033

Atlanta VA Medical Center, Decatur

30322

Emory University, Atlanta

32608

University of Florida, Gainesville

37232

Vanderbilt University, Nashville

44106

Cleveland VA Medical Center, Cleveland

University Hospitals, Cleveland

52242

University of Iowa, Iowa City

55455

University of Minnesota, Minneapolis

60611

Northwestern University, Chicago

80045

University of Colorado, Aurora

84108

University of Utah, Salt Lake City

92037

University of California San Diego, San Diego

92161

VA Medical Center San Diego, San Diego

95817

University of California Davis, Sacramento

97239

Oregon Health and Science University, Portland

98185

University of Washington, Seattle

02199

Brigham and Women's Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

lead

Johns Hopkins University

OTHER