Study concept and design: Fritz, Asche, Brennan.
Acquisition, analysis, or interpretation of data: Fritz, Magel, McFadden, Asche, Thackeray, Meier, Brennan.
Drafting of the manuscript: Fritz, McFadden, Asche.
Critical revision of the manuscript for important intellectual content: Fritz, Magel, McFadden, Asche, Thackeray, Meier, Brennan.
Statistical analysis: McFadden, Asche.
Obtained funding: Fritz, Asche.
Administrative, technical, or material support: Fritz, Magel, McFadden, Thackeray, Meier, Brennan.
Study supervision: Fritz, Thackeray, Brennan.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Fritz reports receiving personal fees from Focus On Therapeutic Outcomes. No other disclosures were reported.
Funding/Support: This study was funded by grant 1R18HS018672 from the Agency for Healthcare Research and Quality. The study was supported by the University of Utah Study Design and Biostatistics Center, with funding in part through grant 5UL1TR001067-02 (formerly 8UL1TR000105 and UL1RR025764) from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health.
Role of the Funder/Sponsor: The Agency for Healthcare Research and Quality had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data and Safety Monitoring Board: Roger Chou, MD (Oregon Health and Science University), Anthony Delitto, PhD, PT, FAPTA (University of Pittsburgh), Richard Holubkov, PhD (University of Utah), John Childs, PhD, PT, MBA, FAPTA (US Army-Baylor University Doctoral Program in Physical Therapy), and Lucy Savitz, PhD (Intermountain Healthcare).
Additional Contributions: We thank the following research assistants for their roles in delivering the physical therapy intervention: Kate Thayn, DPT (Intermountain Healthcare); Dershung Yang, PhD, and Niina Haas, MA (both from BrightOutcome), developed the electronic data collection platform and database, contributed to the data management, and oversaw the web maintenance. Tom Greene, PhD, provided oversight for the statistical planning and data analysis of this trial. All of the people acknowledged above were compensated for their work (including the data and safety monitoring board) in this study.