Optimizing Pain Self-Management in Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT06038240 |
Recruitment Status :
Recruiting
First Posted : September 14, 2023
Last Update Posted : December 6, 2023
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Condition or disease | Intervention/treatment | Phase |
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Osteo Arthritis Knee Knee Pain Chronic Surgery | Behavioral: Savoring Meditation Behavioral: Pain Self-Management and Education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Optimizing Pain Self-Management in Total Knee Arthroplasty |
Actual Study Start Date : | November 27, 2023 |
Estimated Primary Completion Date : | September 2026 |
Estimated Study Completion Date : | September 2027 |
Arm | Intervention/treatment |
---|---|
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.
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Behavioral: Savoring Meditation
Participants will learn about pain neuroscience and will learn/practice a positive emotion generative practice (Savoring Meditation). |
Pain Self-Management and Education
Education Control
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Behavioral: Pain Self-Management and Education
Participants will learn about the biopsychosocial drivers of chronic pain. |
- Numeric Rating Scale for Clinical Pain [ Time Frame: Baseline to 3 months post-surgery ]Average pain intensity on numeric rating scale (range of 0-100; higher scores indicate greater pain), aggregated across Ecological Momentary Assessment observations
- Opioid Use [ Time Frame: Baseline to 3-months post-surgery ]Morphine Equivalent Units per day, as assessed with Ecological Momentary Assessment
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) [ Time Frame: Baseline to 3 months post-surgery ]Measure of pain and function following knee surgery (range of 1-100; higher scores indicate higher level of function)
- Positive and Negative Outcome Schedule-X (PANAS-X) Joviality Subscale [ Time Frame: Baseline to 3-months post-surgery ]Measure of positive emotion (range of 1-5; higher scores indicate greater positive emotion)
- Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: Baseline to 3-months post-surgery ]Measure of anhedonia (range of 14-56; higher scores indicate greater anhedonia)
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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038240
Contact: Patrick Finan, PhD | 4349249514 | tpx4xe@uvahealth.org |
United States, Virginia | |
Fontaine Research Park | Recruiting |
Charlottesville, Virginia, United States, 22903 | |
Contact: Patrick Finan, PhD tpx4xe@uvahealth.org |
Responsible Party: | Patrick Finan, PhD, Harold Carron Professor, University of Virginia |
ClinicalTrials.gov Identifier: | NCT06038240 |
Other Study ID Numbers: |
HSR230005 |
First Posted: | September 14, 2023 Key Record Dates |
Last Update Posted: | December 6, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Deidentified data will be shared upon reasonable request from other researchers, and after a data use agreement has been executed between institutions. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Analytic Code |
Time Frame: | Data will become available after the study is complete and the primary outcomes manuscript has been published. |
Access Criteria: | Access will be granted after a Data Use Agreement has been executed. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |