No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
University of Virginia · Other
Who this trial is looking for
This trial is looking for adults who are planning to have knee surgery due to osteoarthritis. Participants will either practice savoring meditation or take part in a different pain management education program, and there will be follow-up assessments to see how effective they are.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I have been diagnosed with knee osteoarthritis.
I have a treatment plan for unilateral total knee arthroplasty (TKA).
I am willing to comply with the study sessions and procedures.
You may not be able to join if
I am pregnant or I am a child.
I have a severe medical condition that is unstable.
I have a severe psychiatric disorder.
I have a severe alcohol or substance use disorder.
I have used opioids weekly or more in the past 30 days.
I have had another surgery on my knee in the last 6 months.
I have had a total knee arthroplasty before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 experi…
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.
Trial Locations
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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 …
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.
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