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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Meets American College of Rheumatology Classification criteria for knee osteoarthritis

Exclusion Criteria:

• Any inability to complete study procedures, including, but not limited to low English language literacy.

• Unstable medical condition that presents as an absolute or relative contraindication for participation (e.g., unstable angina, poorly controlled diabetes mellitus, end stage renal failure, automated implantable cardioverter-defibrillator that cannot be disabled before RFA).

• Severe untreated bleeding disorder (anticoagulants may be continued during phase II treatments in most patients)

• Severe vision or hearing impairment or serious cognitive impairment that could interfere with consent or outcome assessment

• Poorly controlled serious psychiatric condition

• Active substance abuse

• Scheduled joint replacement on the affected knee

• History of unilateral total knee arthroplasty (TKA) with complaints of KOA pain limited to the operated knee

• Ulcers or an open wound in the region of the index knee