Empowered Relief for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
"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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Delivery
Participants complete the live Empowered Relief online class, a 2-hour intervention equipping them with evidence-based behavioral pain management skills
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Empowered Relief
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients will be provided with a handout from the U.S. Pain Foundation titled "Self Management Strategies"
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
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