Persistent Relief: Protocol for a Feasibility Randomized Trial Comparing Yoga to Pain Education for Patients With
Dennis Muñoz-Vergara1,2, Robert B Saper3, Sat Bir S Khalsa4
1Osher Center for Integrative Health, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.
Background:
Persistent post-surgical pain, a chronic pain syndrome with few effective treatments, has spiked in recent years due to the increase in life expectancy and the number of surgical procedures performed. Studies have shown that non-pharmacological interventions, such as yoga, may help manage chronic pain, reducing pain severity and interference. Despite emerging evidence of the efficacy of yoga in managing chronic pain symptoms, rigorous studies evaluating its use in patients with persistent post-surgical pain have not been conducted. This study describes protocols used in Persistent Relief, an ongoing pilot randomized controlled trial comparing yoga to chronic pain health education. Results from a modified Delphi validation process used to adapt a yoga program for chronic low back pain to the unique needs of this patient population are also included.
Methods/Design:
Fifty patients aged ≥18 with persistent post-surgical pain for at least 3 months and a mean pain severity of 4/10 on the Brief Pain Inventory are randomized to a 12-week yoga program (12, 75-minute sessions) or a chronic pain health education program (12, 15-30-minute sessions), followed by a 12-week follow-up period. Results of an iterative Delphi validation process led by an interdisciplinary expert panel indicated strong endorsement of the Yoga Program (across 7 experts and 9 questions; mean=6.7 [SD=0.64] on a 7-point Likert scale). Primary outcomes include pre-specified feasibility and acceptability metrics. Secondary outcomes include a battery of biopsychosocial measures, with the Brief Pain Inventory as the primary clinical outcome for a future fully powered trial.
Discussion:
Results will provide preliminary data to inform modifications for a future fully powered study evaluating the efficacy of yoga integrated into the management of persistent post-surgical pain. Findings will also inform the design of future studies examining the biological mechanisms underlying the integrative use of yoga to prevent or resolve chronic pain syndromes.
Clinicaltrialsgov Identifier:
NCT06949007.