Empowered Relief Study

Osteoarthritis (OA)

"Empowered Relief" (ER) Intervention was developed by Beth Darnall, PhD at what is now the Stanford Pain Relief Innovations Lab. Our design is a randomized 3-arm study with test treatment, active control, and placebo arms. Our goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the standard of care - group pain-CBT. Treatment allocation is randomized to minimize confounder effects. Statisticians performing analyses will be blinded. The primary objective of this study is to evaluate the efficacy of Empowered Relief (a novel, single-session (2-hour), evidence-based online pain management class) on reducing pain burden and improving quality of life in patients with advanced osteoarthritis. Empowered Relief is designed to compress key cognitive behavioral therapy (CBT) skills, mindfulness principles, and pain neuroscience education into a brief, scalable format. Specifically, the study aims to: Evaluate Clinical Outcomes: Determine whether the intervention reduces pain burden and enhances mobility. Assess Psychological & Behavioral Impact: Examine whether the intervention improves patient-reported understanding of pain, fosters self-efficacy, and increases perceived control, thereby promoting active engagement in their own pain management. Subject Population: The subject population consists of adult patients diagnosed with advanced osteoarthritis (KL Grade 3-4) who have been deferred from total hip or total knee arthroplasty (THA/TKA). Deferment criteria for this population include existing medical, surgical, behavioral, or personal barriers that currently preclude them from undergoing joint replacement surgery. This population is particularly vulnerable to prolonged suffering, decreased mobility, and compounding psychosocial distress while managing severe somatic pain without immediate surgical options. Main Research Procedures: The study will utilize a prospective, longitudinal design to measure the impact of the Empowered Relief intervention on the target population. The main procedures include: Intervention Delivery: Eligible participants will complete the live Empowered Relief online class (via Zoom) with a certified instructor (Dr. Caryn Lindsey), a 2-hour intervention equipping them with accessible, evidence-based behavioral pain management skills. Data Collection Schedule: Participants will be assessed at three distinct time points: Baseline (pre-intervention), 4-weeks post-treatment, and 8-weeks post-treatment.

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United States