Optimizing Pain Self-Management in Total Knee Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Virginia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Savoring Meditation

    Behavioral

    Participants will learn about pain neuroscience and will learn/practice a positive emotion generative practice (Savoring Meditation).

  • Pain Self-Management and Education

    Behavioral

    Participants will learn about the biopsychosocial drivers of chronic pain.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Savoring MeditationExperimental treatment 1 intervention
Group B: Pain Self-Management and EducationOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to 3 months post-surgery
2

Opioid Use

Number of opioid prescription refills post-surgery

Time frame
Baseline to 3-months post-surgery

Secondary outcomes

1

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)

Time frame
Baseline to 3 months post-surgery
2

Positive and Negative Outcome Schedule-X (PANAS-X) Joviality Subscale

Measure of positive emotion (range of 1-5; higher scores indicate greater positive emotion)

Time frame
Baseline to 3-months post-surgery
3

Snaith-Hamilton Pleasure Scale (SHAPS)

Measure of anhedonia (range of 14-56; higher scores indicate greater anhedonia)

Time frame
Baseline to 3-months post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.