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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based CBT | Experimental | All participants will receive four individual mindfulness-based CBT sessions. |
|
| Treatment as Usual | No Intervention | All participants will undergo surgery as usual, with no additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Cognitive Behavioral Therapy | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Edwards, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital Pain Management Center | Chestnut Hill | Massachusetts | 02467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36394250 | Derived | Pester BD, Wilson JM, Yoon J, Lazaridou A, Schreiber KL, Cornelius M, Campbell CM, Smith MT, Haythornthwaite JA, Edwards RR, Meints SM. Brief Mindfulness-Based Cognitive Behavioral Therapy is Associated with Faster Recovery in Patients Undergoing Total Knee Arthroplasty: A Pilot Clinical Trial. Pain Med. 2023 Jun 1;24(6):576-585. doi: 10.1093/pm/pnac183. |
| Label | URL |
|---|---|
| Local site recruitment link | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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|
| 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 |
| D012216 |
| Rheumatic Diseases |