The objectives here were to present a model of transparent reporting and pragmatic
RCT design adaptation, and to promote discussion regarding best practices for overcoming
the challenge of detecting intervention-specific changes in pain within the context
of variable psychosocial factors due to the pandemic. Methods included an ongoing
randomized, double-blind, placebo-controlled trial is examining the effect of pain
education combined with exercise on pain in patients with chronic Achilles tendinopathy.
We hypothesized that a biopsychosocial approach to patient education would reduce
movement-evoked pain more than standard care (biomedical education and exercise).
Since March 2020, challenges have included a temporary halt of in-person human subjects
research, adapting virtual screening procedures to maintain confidentiality and safety,
need to obtain telehealth license in multiple states, inability to use specialized
laboratory equipment to evaluate secondary outcomes, and gradual resumption of in-person
visits with PPE. As COVID-19 prevented the trial from proceeding as planned, we adapted
our design to both exploit new opportunities and maintain high standards of transparency
and rigor. We maintained study enrollment by modifying screening, evaluation, and
treatment to accommodate virtual participation with consistent content. We adjusted
our aims to include an a priori hypothesis that differential effects of a biopsychosocial
versus biomedical approach on pain may be magnified during a pandemic. Additionally,
strategies developed to adapt to an altered research-environment may be useful tools
for future RCTs to facilitate participant recruitment and retention. We logged changes
in a time-stamped manner on Open Science Framework; full disclosure will be ensured
in final reports at Clinicaltrials.gov and publications. Adaptive designs are at risk
of low confidence unless full transparency is integrated into research processes.
Our own efforts to integrate changes to research design and conduct, with contemporary
standards of transparency and rigor, provide opportunities for future research practice
during and post-COVID. Funding for this study was provided by the National Institute
of Arthritis Musculoskeletal and Skin Disease (NIAMS) research grant R00 AR071517
and by the Collaborative Research Grant from the International Association for the
Study of Pain (IASP). Research reported in this publication was supported by the National
Center for Advancing Translational Sciences of the National Institutes of Health under
Award Number UL1TR002537. These funding sources had no role in study design, collection,
analysis/interpretation of data, or decision on submission for publication. The content
is solely the responsibility of the authors and does not necessarily represent the
official views of the National Institutes of Health.
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