Clinical Trials Logo

Clinical 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). 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06038240
Study type Interventional
Source University of Virginia
Contact Patrick Finan, PhD
Phone 4349249514
Email tpx4xe@uvahealth.org
Status Recruiting
Phase N/A
Start date November 27, 2023
Completion date September 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Enrolling by invitation NCT05534490 - Surgery and Functionality in Older Adults N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT06397287 - PROM Project Urology
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03432429 - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Recruiting NCT06103136 - Maestro 1.0 Post-Market Registry
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04059328 - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A