A Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Examination of a Recent Study of Massage and Relaxation Therapy Effectiveness

Abstract

Purpose: This presentation will discuss the pragmatic methodological approach of a recently completed NIH sponsored study of clinical massage therapy (CMT) and progressive muscle relaxation (PMR). While CMT and PMR have demonstrated efficacy for chronic low back pain (CLBP), their effectiveness in the real world of health care practice is only now being evaluated. Pragmatic studies have been recommended by NIH and the Institute of Medicine to address effectiveness questions.

Methods: Critical discussion among 2 key study team members and 2 outside reviewers analyzed the study protocol for accordance with pragmatic vs. explanatory characteristics developed in the PRECIS tool by Thorpe et al. (2009). Scores for each of 10 domains were used to create an overall visual representation of the extent to which this study reflects a pragmatic research approach.

Results: The visual wagon wheel reflecting the current study's “standing” on the Thorpe model will be presented. The study most strongly reflected a pragmatic approach in the following domains: Eligibility Criteria, Flexibility of Experimental Intervention, Practitioner Expertise, Outcomes, and Participant Compliance. Areas that the current study neutrally reflected a pragmatic approach or reflects more of an explanatory approach included Follow-up Intensity, Analysis of the Primary Outcome, and Practitioner Adherence.

Conclusion: To our knowledge, this is the first CAM related research trail that has retrospectively critiqued its study design utilizing the PRECIS tool. CAM investigators may utilize this self-critique and the PRECIS tool to develop study designs and prospectively critique the extent to which pragmatic approaches apply. Audience participants will gain understanding of methodologies and techniques of pragmatic studies.