Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Fontaine Research Park
Charlottesville, Virginia, United States, 22903
Actively Recruiting
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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