Highlights
- •Treatment effects based on alternative ecological momentary assessments (EMA) indices of pain intensity were compared.
- •Over 1 million EMA pain intensity ratings over 20+ weeks of treatment were analyzed.
- •Multiple EMA pain indices detected treatment effects in pain clinical trials.
- •Changes in all EMA indices were associated with patient global impression of change.
- •Alternative pain indices may inform understanding of clinical trial outcomes.
Abstract
Pain intensity represents the primary outcome in most pain clinical trials. Identifying
methods to measure aspects of pain that are most sensitive to treatment may facilitate
discovery of effective interventions. In this third of 3 articles examining alternative
indices of pain intensity derived from ecological momentary assessments (EMA), we
compare treatment effects based on Average Pain, Maximum Pain, Minimum Pain, Pain
Variability, Time in High Pain, Time in Low Pain, and Pain After Wake-Up. We also
examine which indices contribute to Patient Global Impressions of Change (PGIC). Data
came from 2 randomized, double-blind, placebo-controlled trials examining the efficacy
of milnacipran for fibromyalgia treatment; 2,084 patients provided >1 million EMA
pain intensity ratings over 24 (Study 1) or 26 (Study 2) treatment weeks. Pain Variability
and Time in High Pain produced significantly smaller treatment effects than Average
Pain; other pain indices showed effects that were numerically smaller, but not significantly
different from Average Pain. Changes in all pain indices were significantly associated
with PGIC, with improvements in Maximum Pain and in Pain Variability offering small
incremental contributions to understanding PGIC over Average Pain. Results suggest
that different pain indices could be used to detect treatment effects in pain clinical
trials.
Perspective
Alternative summary measures of pain intensity derived from EMA may broaden the scope
of outcomes useful in pain clinical trials. In this analysis of a pharmacological
treatment for fibromyalgia, most pain summary measures indicated similar effects;
improvements in Maximum Pain and Pain Variability contributed to understanding PGIC
over Average Pain.
Key Words
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Article info
Publication history
Published online: October 23, 2020
Footnotes
Conflict of interest: A.A.S. is a Senior Scientist with the Gallup Organization and a consultant with IQVIA and Adelphi Values, Inc. The remaining authors have no conflict of interest to declare.
This work was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR066200; A.A.S. and S.S., principal investigators).
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© 2020 by United States Association for the Study of Pain, Inc.
