Knee Replacement, Osteoarthritis, Knee
Conditions
Keywords
CBT
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.
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.
Interventions
BEHAVIORALMindfulness-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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age 45 or older, 2. Meet the American College of Rheumatology criteria for knee OA, 3. Scheduled to undergo total knee arthroplasty, 4. Facility with the English language that is adequate to complete study procedures
Exclusion criteria
1. Cognitive impairment preventing completion of study assessment procedures. 2. Myocardial infarction within the past 12 months. 3. Presence of Severe Raynaud's or severe neuropathy, 4. Active vasculitis or severe peripheral vascular disease, 5. Current infection, 6. Use of oral steroids, 7. Recent history of substance abuse or dependence, 8. Known anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) | baseline | Measure of pain severity and pain interference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Sensory Testing (QST) | baseline | Measures of responses to standardized stimuli |
| Pain Catastrophizing Scale | baseline | Assess catastrophic thinking related to pain |
| PROMIS-SF | baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Edwards, PhD
Brigham and Women's Hospital
Outcome results
None listed