AUTHOR=Allsop Vivianne L. , Schmid Arlene A. , Miller Kristine K. , Slaven James E. , Daggy Joanne K. , Froman Amanda , Kline Matthew , Sargent Christy , French Dustin D. , Ang Dennis , Van Puymbroeck Marieke , Schalk Nancy L. , Bair Matthew J. 

TITLE=The Pain Outcomes Comparing Yoga vs. Structured Exercise (POYSE) Trial in Veterans With Fibromyalgia: Study Design and Methods

JOURNAL=Frontiers in Pain Research

VOLUME=Volume 3 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/pain-research/articles/10.3389/fpain.2022.934689

DOI=10.3389/fpain.2022.934689

ISSN=2673-561X

ABSTRACT=Background: Fibromyalgia is a common pain condition that often leads to significant disability. Unfortunately, the effectiveness of most medications for fibromyalgia is limited and there is a need for alternative, non-pharmacological therapies. Yoga and aerobic exercise are both evidence-based non-pharmacological treatments for fibromyalgia. However, no prior studies have directly compared the effectiveness of yoga versus exercise. 
Objective: This paper describes the study design and recruitment outcomes of the Pain Outcomes comparing Yoga versus Structured Exercise (POYSE) Trial, a 2-arm randomized comparative effectiveness trial. 
Methods: Veterans with fibromyalgia, defined by the 2010 American College of Rheumatology diagnostic criteria, who also experienced at least moderate pain severity were enrolled.  Participants were randomized to either a 12-week yoga-based or structured exercise intervention and will undergo comprehensive outcome assessments at baseline, 1, 3, 6, and 9 months by interviewers blinded to treatment assignment. The primary outcome will be the overall impact and severity of fibromyalgia as measured by total the Fibromyalgia Impact Questionnaire-Revised. Secondary outcomes include depression, anxiety, health-related quality of life, pain beliefs, fatigue, sleep, and self-efficacy.
Results: A total of 2,671 recruitment letters were sent to potential participants with fibromyalgia. Of these potential participants, 623 (23.3%) were able to be contacted by telephone and had their eligibility assessed. Three hundred seventy-one of those interviewed were found to be eligible (59.6%) and 256 (69.0%) agreed to participate and were randomized to the YOGA (n = 129) or SEP (n = 127) arms of the trial.
Conclusions: Clinicians are faced with numerous challenges in treating patients with fibromyalgia. The interventions being tested in the POYSE trial have the potential to provide primary care and other care settings with new treatment options for clinicians while simultaneously providing much needed relief for patients suffering from fibromyalgia.