Empowered Relief Study

NCT07562750 | Not Yet Recruiting

• 1 other identifier: STUDY00004779
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

"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.

Conditions

Osteoarthritis (OA)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Test Treatment

EXPERIMENTAL

Behavioral: Empowered Relief

Educational Materials

ACTIVE COMPARATOR

Patients will be provided with a handout from the U.S. Pain Foundation titled "Self Management Strategies"

Behavioral: "Self Management Strategies" handout

Interventions

Empowered Relief BEHAVIORAL

2-hour pain management course

Test Treatment

"Self Management Strategies" handout BEHAVIORAL

"Self Management Strategies" is an educational handout from the US Pain Foundation

Educational Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 or older who are eligible and interested in enrolling

You may not qualify if:

• Any records flagged "break the glass" or "research opt out"

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• 3. Wertli, M.M., et al., The Influence of Catastrophizing on Treatment Outcome in Patients With Non-Specific Low Back Pain: A Systematic Review. Spine (Phila Pa 1976), 2013.

  BACKGROUND

• 2. CDC, Prevalence and Most Common Causes of Disability Among Adults --- United States, 2005. MMWR, 2009. 58(16): p. 421-416.

  BACKGROUND

• 1. Freburger, J.K., et al., The rising prevalence of chronic low back pain. Arch Intern Med, 2009. 169(3): p. 251-8.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Jordan Bernstein

CONTACT

5514973176; jordan.bernstein@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 1, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): April 14, 2028
• Study Completion (Estimated): April 16, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)