SKOAP

A sequenced-strategy for improving outcomes in people with knee osteoarthritis pain

About the Study

Currently Recruiting: Participants

Study Timeline: This study is expected to conclude in August 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).

Visit the Study Website

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
  • Age > 50 years old
  • Morning stiffness < 30 minutes
  • Crepitus on knee motion
  • Bony tenderness
  • Bony enlargement
  • No palpable warmth
  • Age > 50 years old
  • Morning stiffness < 30 minutes
  • Crepitus on active motion and osteophytes
  • Age > 50 years old
  • Morning stiffness < 30 minutes
  • Crepitus on knee motion
  • Bony tenderness
  • Bony enlargement
  • No palpable warmth
  • ESR < 40 mm/hour
  • Rheumatoid Factor (RF) < 1:40
  • Synovial fluid signs of osteoarthritis

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