A Multi-Measure, Longitudinal Pain Case Study
Pain clinical trial endpoints often rely on episodic, clinic-based assessments and single pain scores. But subjective pain ratings are highly variable, influenced by mood, sleep, baseline function, and expectations, which contributes to high placebo response and forces sponsors to compensate with larger, costlier trials.
This case study explores how a repeat, multi-measure, at-home measurement strategy more clearly characterized pain resolution and functional recovery following total hip replacement, using surgery as a constrained, real-world model of pain recovery.
Why Pain Clinical Trial Endpoints Miss Recovery
Between clinic visits, meaningful fluctuations in pain, function, and activity go unobserved, so recovery milestones are inferred rather than directly measured. And when improvement is expected, as it is after surgery, the harder questions are when meaningful recovery occurs and whether reductions in pain actually align with real-world functional improvement. Episodic assessment alone cannot answer either.
A Multi-Measure, At-Home Strategy
Koneksa followed 24 participants from baseline through six weeks post-surgery using seven clinical outcome assessments spanning patient-reported, clinician-reported, and performance-based measures, paired with continuous wearable capture of mobility, physiology, and sleep. In-clinic visits were limited to baseline and end of participation. Longitudinal analysis revealed coordinated recovery patterns across domains, including a distinct recovery inflection point that episodic assessment would have missed entirely.
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What You'll Learn
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