Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06038240

Optimizing Pain Self-Management in Total Knee Arthroplasty

Led by University of Virginia · Updated on 2023-12-06

150

Participants Needed

1

Research Sites

196 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of this study is to investigate the efficacy of a positive affect enhancing intervention designed to reduce pain and augment reward system function in knee osteoarthritis (KOA) patients undergoing total knee arthroplasty (TKA). The scientific premise is that patient use of a positive emotion generative practice - savoring meditation, which has been demonstrated to reduce pain in experimental laboratory settings, enhanced with a pain neuroscience education component about reward system dysfunction as a chronic pain mechanism - is optimally suited to reduce postsurgical pain and augment reward system functioning relative to a Pain Self-Management and Education (PSME) condition. We will randomize 150 patients with KOA undergoing unilateral TKA to a brief, 4-session (20-30 minutes each) course of Savoring Meditation (SM; n = 75) or PSME (n = 75) delivered remotely by trained interventionists in a one-on-one format. We will assess pain and as well as pain-related risk and protective factors both via questionnaire and via weeklong ecological momentary assessment (EMA) data bursts on the following schedule: baseline, post-surgery, and 3-month follow-up. In addition, participants will attend laboratory testing sessions at baseline and 6-weeks post-surgery, during which affective pain modulation and electroencephalographic (EEG) brain biomarkers associated with pain and affect will be recorded. Participants in SM be encouraged to practice their savoring for 5 minutes/day during the week following surgery, as well as to use it to manage pain flares in a self-directed manner.

CONDITIONS

Official Title

Optimizing Pain Self-Management in Total Knee Arthroplasty

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 85 years
  • Have a physician-confirmed plan to undergo unilateral total knee arthroplasty
  • Have a physician-confirmed diagnosis of knee osteoarthritis
  • Willing and able to comply with scheduled sessions and study procedures
Not Eligible

You will not qualify if you...

  • Pregnant women, children, prisoners, cognitively impaired, or non-English-speaking individuals
  • Current unstable or severe medical conditions
  • Current severe psychiatric disorders such as schizophrenia, psychosis, or other unstable psychiatric conditions
  • Current severe alcohol or substance use disorder
  • Weekly or more frequent opioid use in the past 30 days (other than tramadol or codeine)
  • Surgery on the affected knee in the last 6 months
  • Previous total knee arthroplasty on the affected knee

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fontaine Research Park

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

P

Patrick Finan, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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