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NCT06038240 · ClinicalTrials.gov registry record · NA
Optimizing Pain Self-Management in Total Knee Arthroplasty
A NA study of Surgery and Osteo Arthritis Knee, sponsored by University of Virginia.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06038240 is a NA study of Surgery and Osteo Arthritis Knee that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 150 participants, below the 52,850-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06038240, a NA study of Surgery and Osteo Arthritis Knee, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BEHAVIORAL Savoring Meditation
- BEHAVIORAL Pain Self-Management and Education
Study Locations (1)
Virginia
- Fontaine Research Park - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2027-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06038240
The ClinicalTrials.gov registry entry for NCT06038240 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52,850-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Savoring Meditation is the first listed.
NCT06038240 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT06038240 about?
NCT06038240 is a clinical study titled "Optimizing Pain Self-Management in Total Knee Arthroplasty". 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 emo...
What is the current status of trial NCT06038240?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2023-11-27. Estimated completion is 2027-09.
What conditions does trial NCT06038240 study?
This clinical trial studies the following conditions: Surgery, Osteo Arthritis Knee, Knee Pain Chronic.
What interventions are being tested in trial NCT06038240?
The interventions under investigation include: Savoring Meditation (BEHAVIORAL), Pain Self-Management and Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT06038240?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06038240 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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