NCT06038240 Optimizing Pain Self-Management in Total Knee Arthroplasty
| NCT ID | NCT06038240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Osteo Arthritis Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-11-27 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06038240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Osteo Arthritis Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06038240 currently recruiting?
Yes, NCT06038240 is actively recruiting participants. Contact the research team at tpx4xe@uvahealth.org for enrollment information.
Where is the NCT06038240 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06038240 clinical trial?
NCT06038240 is sponsored by University of Virginia. The trial plans to enroll 150 participants.