Recruiting

Pain Self-Management

Sponsor:

University of Virginia

Code:

NCT06038240

Conditions

Osteo Arthritis Knee

Knee Pain Chronic

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Savoring Meditation

Pain Self-Management and Education

Study Details

Brief summary:

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

Osteo Arthritis Knee

Knee Pain Chronic

Surgery

Study ID

NCT06038240

Start date

Nov 27, 2023

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-85 years old.
  • Have a physician-confirmed treatment plan to undergo unilateral TKA along with physician-confirmed knee osteoarthritis diagnosis.
  • Willingness and ability to comply with scheduled sessions and study procedures

Exclusion Criteria:

  • Member of a vulnerable population including pregnant women, children, prisoners, cognitively impaired, and non-English-speaking subjects.
  • Current unstable, severe medical comorbidity.
  • Current severe psychiatric comorbidity (e.g., schizophrenia, psychosis, or other unstable psychiatric disorder).
  • Current severe alcohol or substance use disorder.
  • Weekly or more frequent use of opioids in the past 30 days (other than tramadol and/or codeine) for therapeutic or non-therapeutic purposes.
  • Other surgery of the affected knee in the last 6 months.
  • Previous TKA.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Savoring Meditation

Participants will learn about pain neuroscience and will learn/practice a positive emotion generative practice (Savoring Meditation).

Pain Self-Management and Education

Participants will learn about the biopsychosocial drivers of chronic pain.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Fontaine Research Park

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Patrick Finan, PhD

tpx4xe@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Aug 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-08-17.