Non-Surgical Interventions for Knee Osteoarthritis
(SKOAP Trial)
Trial Summary
What is the purpose of this trial?
There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.
Research Team
Steven Cohen, MD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for individuals with knee osteoarthritis who meet the American College of Rheumatology criteria. It's not suitable for those with severe sensory impairments, cognitive issues that affect consent or assessments, scheduled joint replacements, open wounds on the knee, inability to follow study procedures, unstable medical conditions like uncontrolled diabetes or heart problems, history of total knee arthroplasty with pain only in the operated knee, untreated severe bleeding disorders or serious psychiatric conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Treatment
Participants receive conservative behavioral and non-opioid pharmacological treatments including Duloxetine, pain coping skills training, and guideline-recommended treatments for knee osteoarthritis.
Phase 2: Treatment
Participants receive procedural interventions such as intra-articular injections or nerve procedures.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of opioid use and pain.
Treatment Details
Interventions
- Best Practices
- Duloxetine
- Intra-Articular Injection
- Nerve Procedure with long acting blocks
- Nerve Procedure with nerve ablation
- Pain Coping Skills Training
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Pacira Pharmaceuticals, Inc
Industry Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator