Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038240
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-09-07
Brief Title:
Optimizing Pain Self-Management in Total Knee Arthroplasty
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Optimizing Pain Self-Management in Total Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 minutesday 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 ie 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 eg central and peripheral sensitization whose efficacy appears to be optimized when combined with an additional active treatment eg physical therapy informed by the patents 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
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 eg central and peripheral sensitization whose efficacy appears to be optimized when combined with an additional active treatment eg physical therapy informed by the patents 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None