Prediction of Outcomes Following Total Knee Replacement- Pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Brief Pain Inventory (BPI)
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Robert Edwards
Clinical Psychologist
Brigham and Women's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Brief Pain Inventory (BPI)
Time Frame: 6-months
Measure of pain severity and pain interference
Secondary Outcomes
- Quantitative Sensory Testing (QST)(3-months)
- The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)(6-months)
- Pain Catastrophizing Scale(6-months)
- PROMIS-SF(6-months)