Optimizing Pain Self-Management in Total Knee Arthroplasty

NCT06038240 | Recruiting

• 1 other identifier: HSR230005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Osteo Arthritis Knee; Knee Pain Chronic; Surgery

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline to 3 months post-surgery

• Opioid Use

  Morphine Equivalent Units per day, as assessed with Ecological Momentary Assessment

  Baseline to 3-months post-surgery

Secondary Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)

  Baseline to 3 months post-surgery

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

  Baseline to 3-months post-surgery

• Snaith-Hamilton Pleasure Scale (SHAPS)

  Baseline to 3-months post-surgery

Study Arms (2)

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.

Behavioral: Savoring Meditation

Pain Self-Management and Education

OTHER

Education Control

Behavioral: Pain Self-Management and Education

Interventions

Savoring Meditation BEHAVIORAL

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

Savoring Meditation

Pain Self-Management and Education BEHAVIORAL

Participants will learn about the biopsychosocial drivers of chronic pain.

Pain Self-Management and Education

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Fontaine Research Park

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Patrick Finan, PhD

CONTACT

4349249514; tpx4xe@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Harold Carron Professor

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)