POKR-p: Prediction of Outcomes Following Total Knee Replacement- Pilot
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mindfulness-based CBT All participants will receive four individual mindfulness-based CBT sessions. |
Behavioral: Mindfulness-based Cognitive Behavioral Therapy
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.
|
| No Intervention: Treatment as Usual All participants will undergo surgery as usual, with no additional intervention. |
Outcome Measures
Primary Outcome Measures
- Brief Pain Inventory (BPI) [baseline]
Measure of pain severity and pain interference
- Brief Pain Inventory (BPI) [6-week]
Measure of pain severity and pain interference
- Brief Pain Inventory (BPI) [3-months]
Measure of pain severity and pain interference
- Brief Pain Inventory (BPI) [6-months]
Measure of pain severity and pain interference
Secondary Outcome Measures
- Quantitative Sensory Testing (QST) [baseline]
Measures of responses to standardized stimuli
- Quantitative Sensory Testing (QST) [3-months]
Measures of responses to standardized stimuli
- Pain Catastrophizing Scale [baseline]
Assess catastrophic thinking related to pain
- Pain Catastrophizing Scale [6-week]
Assess catastrophic thinking related to pain
- Pain Catastrophizing Scale [3-months]
Assess catastrophic thinking related to pain
- Pain Catastrophizing Scale [6-months]
Assess catastrophic thinking related to pain
- PROMIS-SF [baseline]
Measures anxiety and depression symptoms
- PROMIS-SF [6-week]
Measures anxiety and depression symptoms
- PROMIS-SF [3-months]
Measures anxiety and depression symptoms
- PROMIS-SF [6-months]
Measures anxiety and depression symptoms
- The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) [baseline]
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.
- The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) [6-week]
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.
- The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) [3-months]
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.
- The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) [6-months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 45 or older,
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Meet the American College of Rheumatology criteria for knee OA,
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Scheduled to undergo total knee arthroplasty,
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Facility with the English language that is adequate to complete study procedures
Exclusion Criteria:
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Cognitive impairment preventing completion of study assessment procedures.
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Myocardial infarction within the past 12 months.
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Presence of Severe Raynaud's or severe neuropathy,
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Active vasculitis or severe peripheral vascular disease,
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Current infection,
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Use of oral steroids,
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Recent history of substance abuse or dependence,
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Known anemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital Pain Management Center | Chestnut Hill | Massachusetts | United States | 02467 |
Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Robert Edwards, PhD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2010P000978-p