Developing and employing a 'responsive manualization' in the 'Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment' comparative effectiveness study.

Objective: The aim of this article is to describe the process used to develop an acupuncture therapy manual for a large effectiveness trial comparing individual care against group care for chronic pain in an underserved population. The design needed to not only ensure research consistency and replicability but also be 'responsive' to real world heterogeneous and evolving presentations in challenging physical settings.

Background: Chronic pain is prevalent in the United States.