CompletedPhase 3

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

United States1,937 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. At least three of the following using history and physical examination: age \>50 years old; morning stiffness \<30 minutes; crepitus on knee motion; bony tenderness; bony enlargement; no palpable warmth
✓. At least one of the following using history, physical examination, and radiographic findings + the presence of osteophytes: age \>50 years old; morning stiffness \<30 minutes; crepitus on active motion and 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; erythrocyte sedimentation rate (ESR) \<40 mm/hour; Rheumatoid Factor (RF) \<1:40; synovial fluid signs of osteoarthritis

What they're measuring

Change in Pain Intensity as assessed by the Modified 4-item Brief Pain Inventory (BPI) Pain Scale

Timeframe: Change from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2

Trial details

NCT IDNCT04504812

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-08

View on ClinicalTrials.gov More Knee Osteoarthritis trials