Optimizing Pain Self-Management in Total Knee Arthroplasty

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06038240
Status
Recruiting
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Conditions

  • Knee Pain Chronic
  • Osteo Arthritis Knee
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Savoring Meditation — BEHAVIORAL
    Participants will learn about pain neuroscience and will learn/practice a positive emotion generative practice (Savoring Meditation).
  • Pain Self-Management and Education — BEHAVIORAL
    Participants will learn about the biopsychosocial drivers of chronic pain.

Study Details

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.

Key Dates

Start date
Nov 27, 2023
Status verified
Nov 2023
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Savoring Meditation
    A 4-session meditation intervention in which participants are trained to generate positive emotional states and focus their awareness on those states throughout the meditation.
  • Other: Pain Self-Management and Education
    Education Control

Primary Outcome Measure

Numeric Rating Scale for Clinical Pain [ Time Frame: Baseline to 3 months post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fontaine Research ParkCharlottesvilleVirginia22903
Patrick Finan, PhD
[email protected]

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By research site
Fontaine Research Park· Charlottesville, VA

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