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临床试验/NCT07562750
NCT07562750尚未招募不适用

Empowered Relief for Osteoarthritis (OA)

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Pain Catastrophizing Scale (PCS)

研究概览

简要总结

"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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Test Treatment

Experimental

干预措施: Empowered Relief (Behavioral)

Educational Materials

Active Comparator

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

干预措施: "Self Management Strategies" handout (Behavioral)

结局指标

主要结局

Pain Catastrophizing Scale (PCS)

时间窗: Once at baseline, then at weeks 2, 4, 8, and 12.

NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

时间窗: Once at baseline, then at weeks 2, 4, 8, and 12

Questions related to pain, physical function, and depression.

Pain Self-Efficacy Questionnaire

时间窗: Once at baseline, then at weeks 2, 4, 8, and 12

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caryn Lindsey

Principal Investigator

Cedars-Sinai Medical Center

研究点 (1)

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