Osteo Arthritis KneeNCT06038240
Optimizing Pain Self-Management in Total Knee Arthroplasty
A study testing Savoring Meditation and Pain Self-Management and Education in people with Osteo Arthritis Knee and Knee Pain Chronic, run by University of Virginia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee, Knee Pain Chronic, Surgery
- What is being tested?
- Savoring Meditation and Pain Self-Management and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fontaine Research Park
Charlottesville, Virginia, 22903
Patrick Finan, PhD, tpx4xe@uvahealth.org
About this study
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.
Read the detailed description
Total knee arthroplasty (TKA) is an increasingly utilized, end-stage, cost-effective treatment for knee osteoarthritis (OA), one of the leading causes of disability worldwide whose hallmark symptoms include pain, stiffness, limited range of motion, and physical mobility limitations. The mechanisms of pain in OA, like most chronic pain conditions, are complex, multifaceted, and involve both central and peripheral sensitization , as well as reward system dysfunction. Despite its overall efficacy, a significant portion of patients with TKA (10-34%) continue to experience painful joints following the procedure , while an estimated 20% are dissatisfied with the outcome of their procedure. Further, an estimated 20% experience significant post-operative psychological distress in the months following surgery, which longitudinally predicts poorer functional outcomes. TKA on average fails to improve pain and function to a level comparable to the general population, or to the level achieved by other joint replacement procedures (i.e., hip arthroplasty) . These limitations highlight an urgent need to investigate safe and scalable strategies to improve TKA outcomes.
Psychosocial processes have a clinically meaningful role in shaping TKA outcomes. Well-established presurgical cognitive and affective risk factors include pain catastrophizing , kinesiophobia , poor outcome expectations and reward system dysfunction . Meanwhile, emerging research suggests that positive, resilience-related factors such as positive affect, vitality, vigor, social support, self-efficacy, and global, trait-like resilience predict more favorable TKA outcomes.
Major Gap in Knowledge
Despite known, modifiable psychological risk and resilience factors known to impact TKA outcomes, only recently have psychosocial processes in TKA been targeted in clinical trials. There are a handful of investigations which have variously employed psychoeducation, guided imagery, motivational interviewing, and cognitive-behavioral approaches, which have demonstrated modest to poor efficacy in impacting postsurgical pain and function. Pain neuroscience education (PNE) is a relatively recent psychosocial intervention approach to chronic pain that educates patients on the modern neuroscientific understanding of mechanisms (e.g., central and peripheral sensitization), whose efficacy appears to be optimized when combined with an additional active treatment (e.g., physical therapy) informed by the patent's reconceptualization of pain (away from biomedical or biomechanical understanding and towards a modern neuroscientific understanding) achieved through PNE. Initial studies on PNE alone in TKA patients show a favorable effect on patient satisfaction with the TKA procedure and psychosocial risk factors including pain catastrophizing and kinesiophobia but no effect on pain or function.
How Proposed Work Will Fill the Gaps
The present study will address major gaps in knowledge by testing a novel prophylactic psychological intervention for TKA patients that targets reward system dysfunction, a central driver of chronic pain states. Specifically, the study will test a novel Savoring Meditation (SM) intervention, which teaches patients how to augment positive affective functioning via meditating on a positive autobiographical memory. In addition, using a pain neuroscience education framework, SM will also educate participants on the neurophysiological basis for engaging in savoring meditation. Specifically, the intervention will educate patients about the reward system in the brain, and how deficits in reward system functioning serve to maintain pain. Subsequently, the intervention will explain to patients that savoring meditation has been empirically shown and is optimally suited to reduce pain vis-a-vis augmented reward system functioning. Patients randomized to SM will engage in 4 sessions of SM with a trained interventionist. They will be encouraged to use their SM skills in the postsurgical period to manage pain. The study will compare the efficacy of SM to a Pain Self-Management and Education (PSME) condition, wherein patients will learn about biological, psychological, and social drivers of pain. The PSME condition will control for therapeutic alliance and treatment expectancies. It is hypothesized that patients who undergo 4 sessions of SM will demonstrate reduced clinical pain and prescription opioid use across major assessment timepoints (post-treatment, 6-weeks, and 3-months), relative to PSME. Reward system function measured via self-report, affective pain modulation task performance, and electroencephalographic (EEG) based biomarkers will be investigated as a secondary outcome.
- Conditions
- Osteo Arthritis Knee, Knee Pain Chronic, Surgery
- Being tested
- Savoring Meditation, Pain Self-Management and Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savoring MeditationBehavioural
Participants will learn about pain neuroscience and will learn/practice a positive emotion generative practice (Savoring Meditation).
Pain Self-Management and EducationBehavioural
Participants will learn about the biopsychosocial drivers of chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| Savoring Meditation | Experimental | 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. Receives: Behavioral: Savoring Meditation |
| Pain Self-Management and Education | Other | Education Control Receives: Behavioral: Pain Self-Management and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale for Clinical Pain
Average pain intensity on numeric rating scale (range of 0-100; higher scores indicate greater pain), aggregated across Ecological Momentary Assessment observations
Measured: Baseline to 3 months post-surgery
Opioid Use
Number of opioid prescription refills post-surgery
Measured: Baseline to 3-months post-surgery
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Measure of pain and function following knee surgery (range of 1-100; higher scores indicate higher level of function)
Measured: Baseline to 3 months post-surgery
Positive and Negative Outcome Schedule-X (PANAS-X) Joviality Subscale
Measure of positive emotion (range of 1-5; higher scores indicate greater positive emotion)
Measured: Baseline to 3-months post-surgery
Snaith-Hamilton Pleasure Scale (SHAPS)
Measure of anhedonia (range of 14-56; higher scores indicate greater anhedonia)
Measured: Baseline to 3-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start27 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Finan, PhD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038240
- Sponsor's protocol ID
- HSR230005
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared upon reasonable request from other researchers, and after a data use agreement has been executed between institutions.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pain Self-Management in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06038240
- Acronym / sponsor ID
- HSR230005
- Conditions
- Osteo Arthritis Knee, Knee Pain Chronic, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Total knee arthroplasty (TKA) is an increasingly utilized, end-stage, cost-effective treatment for knee osteoarthritis (OA), one of the leading causes of disability worldwide whose hallmark symptoms include pain, stiffness, limited range of motion, and physical mobility limitations. The mechanisms of pain in OA, like most chronic pain conditions, are complex, multifaceted, and involve both central and peripheral sensitization , as well as reward system dysfunction. Despite its overall efficacy, a significant portion of patients with TKA (10-34%) continue to experience painful joints following the procedure , while an estimated 20% are dissatisfied with the outcome of their procedure. Further, an estimated 20% experience significant post-operative psychological distress in the months following surgery, which longitudinally predicts poorer functional outcomes. TKA on average fails to improve pain and function to a level comparable to the general population, or to the level achieved by other joint replacement procedures (i.e., hip arthroplasty) . These limitations highlight an urgent need to investigate safe and scalable strategies to improve TKA outcomes.
Psychosocial processes have a clinically meaningful role in shaping TKA outcomes. Well-established presurgical cognitive and affective risk factors include pain catastrophizing , kinesiophobia , poor outcome expectations and reward system dysfunction . Meanwhile, emerging research suggests that positive, resilience-related factors such as positive affect, vitality, vigor, social support, self-efficacy, and global, trait-like resilience predict more favorable TKA outcomes.
Major Gap in Knowledge
Despite known, modifiable psychological risk and resilience factors known to impact TKA outcomes, only recently have psychosocial processes in TKA been targeted in clinical trials. There are a handful of investigations which have variously employed psychoeducation, guided imagery, motivational interviewing, and cognitive-behavioral approaches, which have demonstrated modest to poor efficacy in impacting postsurgical pain and function. Pain neuroscience education (PNE) is a relatively recent psychosocial intervention approach to chronic pain that educates patients on the modern neuroscientific understanding of mechanisms (e.g., central and peripheral sensitization), whose efficacy appears to be optimized when combined with an additional active treatment (e.g., physical therapy) informed by the patent's reconceptualization of pain (away from biomedical or biomechanical understanding and towards a modern neuroscientific understanding) achieved through PNE. Initial studies on PNE alone in TKA patients show a favorable effect on patient satisfaction with the TKA procedure and psychosocial risk factors including pain catastrophizing and kinesiophobia but no effect on pain or function.
How Proposed Work Will Fill the Gaps
The present study will address major gaps in knowledge by testing a novel prophylactic psychological intervention for TKA patients that targets reward system dysfunction, a central driver of chronic pain states. Specifically, the study will test a novel Savoring Meditation (SM) intervention, which teaches patients how to augment positive affective functioning via meditating on a positive autobiographical memory. In addition, using a pain neuroscience education framework, SM will also educate participants on the neurophysiological basis for engaging in savoring meditation. Specifically, the intervention will educate patients about the reward system in the brain, and how deficits in reward system functioning serve to maintain pain. Subsequently, the intervention will explain to patients that savoring meditation has been empirically shown and is optimally suited to reduce pain vis-a-vis augmented reward system functioning. Patients randomized to SM will engage in 4 sessions of SM with a trained interventionist. They will be encouraged to use their SM skills in the postsurgical period to manage pain. The study will compare the efficacy of SM to a Pain Self-Management and Education (PSME) condition, wherein patients will learn about biological, psychological, and social drivers of pain. The PSME condition will control for therapeutic alliance and treatment expectancies. It is hypothesized that patients who undergo 4 sessions of SM will demonstrate reduced clinical pain and prescription opioid use across major assessment timepoints (post-treatment, 6-weeks, and 3-months), relative to PSME. Reward system function measured via self-report, affective pain modulation task performance, and electroencephalographic (EEG) based biomarkers will be investigated as a secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Savoring Meditation | Experimental | Behavioral: Savoring MeditationA 4-session meditation intervention in which participants are trained to generate positive emotional states and focus their awareness on those states throughout the meditation. |
| Pain Self-Management and Education | Other | Behavioral: Pain Self-Management and EducationEducation Control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Savoring MeditationParticipants will learn about pain neuroscience and will learn/practice a positive emotion generative practice (Savoring Meditation). | Behavioural | Savoring Meditation |
| Pain Self-Management and EducationParticipants will learn about the biopsychosocial drivers of chronic pain. | Behavioural | Pain Self-Management and Education |
Primary outcome
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
Number of opioid prescription refills post-surgery
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Time frame: Baseline to 3 months post-surgery
Positive and Negative Outcome Schedule-X (PANAS-X) Joviality Subscale
Time frame: Baseline to 3-months post-surgery
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline to 3-months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared upon reasonable request from other researchers, and after a data use agreement has been executed between institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Savoring Meditation and Pain Self-Management and Education in people with Osteo Arthritis Knee and Knee Pain Chronic, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Finan, PhD (4349249514, tpx4xe@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale for Clinical Pain (time frame: Baseline to 3 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.