About the Study
Currently Recruiting: Participants
Study Timeline: This study is expected to conclude in October 2024.
Study Drug/Intervention: Using a stepped‑care model, Phase 1 participants will be randomly assigned to one of 3 minimally‑invasive treatments, 1A) best practices, 1B) duloxetine in addition to best practices, and 1C) duloxetine combined with PainTRAINER, a structured cognitive-behavioral therapy (CBT)‑informed web-based program, in addition to best practices. Phase 1 participants that note interest in receiving additional treatment, and those inappropriate for Phase 1 care, will be randomly assigned to more invasive Phase 2 procedures, including 2A) intra-articular hyaluronic acid, steroid, and local anesthetic injection (HA+), 2B) genicular nerve block (GNB) with a long-acting local anesthetic, and 2C) radiofrequency ablation (RFA).
ClinicalTrials.gov ID: NCT04504812
Study Objective
This 2-phase study, Sequential Treatments for Knee Osteoarthritis Pain (SKOAP) seeks to determine the comparative-effectiveness of conservative behavioral and non‑opioid pharmacological treatments (Phase 1) and more aggressive interventional treatments (Phase 2) to improve pain and function in participants with KOA.
Participation Criteria
To be eligible to participate in this study, an individual must meet one of the ACR criteria sets, outlined in columns here:
Meets American College of Rheumatology Classification criteria for KOA:
| Knee Pain AND | ||
| At least 3 of the following using history and physical examination | At least 1 of the following using history, physical examination, and radiographic findings + the presence of osteophytes | At least 5 of the following using history, physical examination, and laboratory findings |
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Sponsor/Funding
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Learn More
- PI: Steven Cohen, Renan Castillo, Claudia Campbell (JHU Study Team)
- PL: Helen Boyle