Empowered Relief Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empowered Relief, "Self Management Strategies" handout.
- Who it may be relevant to
- Registry conditions: Osteoarthritis (OA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Empowered Relief for Osteoarthritis (OA)
Overview
"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.
Interventions
- Behavioral Empowered Relief
2-hour pain management course - Behavioral "Self Management Strategies" handout
"Self Management Strategies" is an educational handout from the US Pain Foundation
Primary outcome measures
- Pain Catastrophizing Scale (PCS) [Time frame: Once at baseline, then at weeks 2, 4, 8, and 12.]
- NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Measures [Time frame: Once at baseline, then at weeks 2, 4, 8, and 12]
- Pain Self-Efficacy Questionnaire [Time frame: Once at baseline, then at weeks 2, 4, 8, and 12]
Eligibility criteria
Inclusion criteria
- Adults age 18 or older who are eligible and interested in enrolling
Exclusion criteria
- Any records flagged "break the glass" or "research opt out"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars Sinai — Los Angeles
Publications
- Wertli MM, Burgstaller JM, Weiser S, Steurer J, Kofmehl R, Held U. Influence of catastrophizing on treatment outcome in patients with nonspecific low back pain: a systematic review. Spine (Phila Pa 1976). 2014 Feb 1;39(3):263-73. doi: 10.1097/BRS.0000000000000110. PMID 24253796
- Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6. PMID 19407734
- Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543. PMID 19204216
Identifiers
NCT: NCT07562750 · STUDY00004779