Study design and protocol of a randomized, pragmatic, comparative effectiveness trial evaluating a sequenced strategy for improving outcomes in people with knee osteoarthritis pain (strategy for Knee OsteoArthritis Pain (SKOAP)): Conservative treatment evaluation
Study context
- Population
- Individuals reporting knee OA pain
- Planned comparison
- Best Practices (BP) alone vs BP plus duloxetine vs BP plus duloxetine and painTRAINER
- Primary endpoint
- Pain
Methodological detailsmulti-site, pragmatic, comparative effectiveness, two-phase sequential design, Phase 1 of the trial sequence (conservative treatments), Analysis: modified Intention to Treat (mITT) and two Per-Protocol analyses (PP-ROP and PP-MinED)
- Multi-site
- Pragmatic
- Comparative effectiveness
- Two-phase sequential design
- Phase 1 of the trial sequence (conservative treatments)
- Analysis: modified Intention to Treat (mITT) and two Per-Protocol analyses (PP-ROP and PP-MinED)
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Study design and protocol of a randomized, pragmatic, comparative effectiveness trial evaluating a sequenced strategy for improving outcomes in people with knee osteoarthritis pain (SKOAP): Conservative treatment evaluation. Semin Arthritis Rheum. Published 23 September 2025. doi:10.
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