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"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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Treatment | Experimental |
| |
| Educational Materials | Active Comparator | Patients will be provided with a handout from the U.S. Pain Foundation titled "Self Management Strategies" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowered Relief | Behavioral | 2-hour pain management course |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing Scale (PCS) | Once at baseline, then at weeks 2, 4, 8, and 12. | |
| NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Measures | Questions related to pain, physical function, and depression. | Once at baseline, then at weeks 2, 4, 8, and 12 |
| Pain Self-Efficacy Questionnaire | Once at baseline, then at weeks 2, 4, 8, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Bernstein | Contact | 5514973176 | jordan.bernstein@cshs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24253796 | Background | 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. | |
| 19407734 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2026 | Apr 21, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2026 | Apr 21, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| "Self Management Strategies" handout |
| Behavioral |
"Self Management Strategies" is an educational handout from the US Pain Foundation |
|
| 19204216 | Background | 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. |