Moving towards multiple site outcomes in spinal cord injury pain clinical trials: An issue of clustered observations in trial design and analysis

摘要

IntroductionPain remains a problem for many with spinal cord injury (SCI), and there is a need for sound, randomized clinical trials examining the efficacy of existing and novel therapeutics. SCI-related pain is complex, as more than one type of pain is often experienced. The purpose of this report is to (i) demonstrate how to design and power calculation of a clinical trial of SCI pain using multiple pain sites per individual; (ii) discuss consequences of failing to adjust for this; and (iii) provide intraclass correlation (ICC) estimates for common pain outcome measures that may be used to power future clinical trials in SCI pain.