RECRUITING

Optimizing Pain Self-Management in Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimizing Pain Self-Management in Total Knee Arthroplasty

Quick Facts

Study Start:2023-11-27
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06038240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-85 years old.
  2. * Have a physician-confirmed treatment plan to undergo unilateral TKA along with physician-confirmed knee osteoarthritis diagnosis.
  3. * Willingness and ability to comply with scheduled sessions and study procedures
  1. * Member of a vulnerable population including pregnant women, children, prisoners, cognitively impaired, and non-English-speaking subjects.
  2. * Current unstable, severe medical comorbidity.
  3. * Current severe psychiatric comorbidity (e.g., schizophrenia, psychosis, or other unstable psychiatric disorder).
  4. * Current severe alcohol or substance use disorder.
  5. * Weekly or more frequent use of opioids in the past 30 days (other than tramadol and/or codeine) for therapeutic or non-therapeutic purposes.
  6. * Other surgery of the affected knee in the last 6 months.
  7. * Previous TKA.

Contacts and Locations

Study Contact

Patrick Finan, PhD
CONTACT
4349249514
tpx4xe@uvahealth.org

Study Locations (Sites)

Fontaine Research Park
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Osteo Arthritis Knee
  • Knee Pain Chronic
  • Surgery