Prediction of Outcomes Following Total Knee Replacement- Pilot

Study Overview
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Brief Summary
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This study seeks to examine multiple risk factors as predictors of pain and function following total knee arthroplasty (TKA). Risk factors will be measured pre-surgically using psychophysical testing procedures, multimodal evaluation of sleep, standardized questionnaires. Additionally, this study will collect pilot data on a brief mindfulness-based cognitive-behavioral treatment that may help to improve long-term TKA outcomes. The pilot study compared TKA patients that received brief mindfulness-based cognitive behavioral therapy (MBCBT) to the treatment-as-usual (TAU) group from the parent study.

Detailed Description
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The present study seeks to collect pilot data on a brief mindfulness-based cognitive-behavioral treatment to determine the feasibility of this intervention and its potential benefits. The study includes 6 total contacts, 1 visit before surgery and 3 after surgery, and 2 phone calls. The last visit will be about 6 months after surgery. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold. The research takes place at the Brigham & Women's Pain Management Center, 850 Boylston St, Chestnut Hill.

Official Title
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Prediction of Outcomes Following Total Knee Replacement- Pilot

Conditions
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Osteoarthritis, Knee, Knee Replacement

Intervention / Treatment
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* Behavioral: Mindfulness-based Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45 or older, Meet the American College of Rheumatology criteria for knee OA, Scheduled to undergo total knee arthroplasty, Facility with the English language that is adequate to complete study procedures Exclusion Criteria: Cognitive impairment preventing completion of study assessment procedures. Myocardial infarction within the past 12 months. Presence of Severe Raynaud's or severe neuropathy, Active vasculitis or severe peripheral vascular disease, Current infection, Use of oral steroids, Recent history of substance abuse or dependence, Known anemia

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants will undergo quantitative sensory testing, physical functioning testing, and pain-related outcomes assessment. Participants in the intervention arm will undergo brief mindfulness-based cognitive behavioral sessions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based CBT<br>All participants will receive four individual mindfulness-based CBT sessions. | Behavioral: Mindfulness-based Cognitive Behavioral Therapy<br>* Mindfulness-based CBT methods are based on pain self-management paradigms, and involve the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing), the enhancement of self-efficacy for managing pain, and training in the use of adaptive pain-coping strategies such as relaxation, distraction, and self-talk.<br>|
| No Intervention: Treatment as Usual<br>All participants will undergo surgery as usual, with no additional intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) | Measure of pain severity and pain interference | baseline | 
| Brief Pain Inventory (BPI) | Measure of pain severity and pain interference | 6-week | 
| Brief Pain Inventory (BPI) | Measure of pain severity and pain interference | 3-months | 
| Brief Pain Inventory (BPI) | Measure of pain severity and pain interference | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Sensory Testing (QST) | Measures of responses to standardized stimuli | baseline | 
| Quantitative Sensory Testing (QST) | Measures of responses to standardized stimuli | 3-months | 
| Pain Catastrophizing Scale | Assess catastrophic thinking related to pain | baseline | 
| Pain Catastrophizing Scale | Assess catastrophic thinking related to pain | 6-week | 
| Pain Catastrophizing Scale | Assess catastrophic thinking related to pain | 3-months | 
| Pain Catastrophizing Scale | Assess catastrophic thinking related to pain | 6-months | 
| PROMIS-SF | Measures anxiety and depression symptoms | baseline | 
| PROMIS-SF | Measures anxiety and depression symptoms | 6-week | 
| PROMIS-SF | Measures anxiety and depression symptoms | 3-months | 
| PROMIS-SF | Measures anxiety and depression symptoms | 6-months | 
| The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) | 24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8. | baseline | 
| The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) | 24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8. | 6-week | 
| The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) | 24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8. | 3-months | 
| The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) | 24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8. | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT