Personalized outcomes in neuropathic pain: a clinical relevance and assay sensitivity analysis from a randomized controlled trial.

ABSTRACT:

Objective

To explore the clinical relevance and assay sensitivity of using personalized outcomes using data from a randomized clinical trial (RCT) in people with chemotherapy-induced peripheral neuropathy (CIPN).

Design

This study is a secondary analysis that leveraged data from a RCT of transcutaneous electrical stimulation for CIPN to test whether personalized outcomes could minimize potential floor effects and increase the assay sensitivity of pain clinical trials (ie, ability to detect a true treatment effect).

Setting

Participants were recruited for a RCT from community oncology clinics in the United States.

Participants

Adults with CIPN (N = 72) who reported on average ≥4 intensity (measured via a 7-day baseline diary) for at least 1 of the following pain

SUBMITTER: Saab K 

PROVIDER: S-EPMC11701308 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature