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Optimizing Pain Self-Management in Total Knee Arthroplasty

Primary Purpose

Osteo Arthritis Knee, Knee Pain Chronic, Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Savoring Meditation
Pain Self-Management and Education
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fontaine Research Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Savoring Meditation

Pain Self-Management and Education

Arm Description

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.

Education Control

Outcomes

Primary Outcome Measures

Clinical Pain
Average pain intensity on numeric rating scale, aggregated across Ecological Momentary Assessment observations
Opioid Use
Morphine Equivalent Units per day, as assessed with Ecological Momentary Assessment

Secondary Outcome Measures

Koos Jr
Affective Pain Modulation Task Performance
Positive Emotions
PANAS-X
Anhedonia
SHAPS

Full Information

First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT06038240
Brief Title
Optimizing Pain Self-Management in Total Knee Arthroplasty
Official Title
Optimizing Pain Self-Management in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 (Felson, 2009) whose hallmark symptoms include pain, stiffness, limited range of motion, and physical mobility limitations (NIAMS, 2019). The mechanisms of pain in OA, like most chronic pain conditions, are complex, multifaceted, and involve both central and peripheral sensitization (Bharde et al., 2021), as well as reward system dysfunction (Wang & Ni, 2022). Despite its overall efficacy, a significant portion of patients with TKA (10-34%) continue to experience painful joints following the procedure (Beswick et al., 2012), while an estimated 20% are dissatisfied with the outcome of their procedure (Bourne et al., 2010; Springer & Sotile, 2020). Further, an estimated 20% experience significant post-operative psychological distress in the months following surgery, which longitudinally predicts poorer functional outcomes (Cremeans-Smith et al., 2011). 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) (Jones et al., 2007; Linsell et al., 2006). 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 (Lewis et al., 2015; M. Sullivan et al., 2011), kinesiophobia (Filardo et al., 2017), poor outcome expectations (M. Sullivan et al., 2011; Tilbury et al., 2018) and reward system dysfunction (Lewis et al., 2015). Meanwhile, emerging research suggests that positive, resilience-related factors such as positive affect, vitality, vigor, social support, self-efficacy, and global, trait-like resilience (Nwankwo et al., 2021) predict more favorable TKA outcomes (Cremeans-Smith et al., 2022; Edwards et al., 2022). 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. We are aware of 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 (Bay et al., 2018). 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 (Moseley & Butler, 2015; J. A. Watson et al., 2019). Initial studies on PNE alone in TKA patients show a favorable effect on patient satisfaction with the TKA procedure (Louw et al., 2019) and psychosocial risk factors including pain catastrophizing and kinesiophobia (Lluch et al., 2018) 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, we 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, we will educate patients about the reward system in the brain, and how deficits in reward system functioning serve to maintain pain. Subsequently, we 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. We 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. We hypothesize 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Knee Pain Chronic, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Savoring Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
Pain Self-Management and Education
Arm Type
Other
Arm Description
Education Control
Intervention Type
Behavioral
Intervention Name(s)
Savoring Meditation
Intervention Description
Participants will learn about pain neuroscience and will learn/practice a positive emotion generative practice (Savoring Meditation).
Intervention Type
Behavioral
Intervention Name(s)
Pain Self-Management and Education
Intervention Description
Participants will learn about the biopsychosocial drivers of chronic pain.
Primary Outcome Measure Information:
Title
Clinical Pain
Description
Average pain intensity on numeric rating scale, aggregated across Ecological Momentary Assessment observations
Time Frame
Baseline to 3 months post-surgery
Title
Opioid Use
Description
Morphine Equivalent Units per day, as assessed with Ecological Momentary Assessment
Time Frame
Baseline to 3-months post-surgery
Secondary Outcome Measure Information:
Title
Koos Jr
Description
Affective Pain Modulation Task Performance
Time Frame
Baseline to 3 months post-surgery
Title
Positive Emotions
Description
PANAS-X
Time Frame
Baseline to 3-months post-surgery
Title
Anhedonia
Description
SHAPS
Time Frame
Baseline to 3-months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Finan, PhD
Phone
4349249514
Email
tpx4xe@uvahealth.org
Facility Information:
Facility Name
Fontaine Research Park
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Finan, PhD
Email
tpx4xe@uvahealth.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be shared upon reasonable request from other researchers, and after a data use agreement has been executed between institutions.
IPD Sharing Time Frame
Data will become available after the study is complete and the primary outcomes manuscript has been published.
IPD Sharing Access Criteria
Access will be granted after a Data Use Agreement has been executed.

Learn more about this trial

Optimizing Pain Self-Management in Total Knee Arthroplasty

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