Prediction of Outcomes Following Total Knee Replacement- Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment as Usual
All participants will undergo surgery as usual, with no additional intervention.
Mindfulness-based CBT
All participants will receive four individual mindfulness-based CBT sessions.
干预措施: Mindfulness-based Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: 6-months
Measure of pain severity and pain interference
次要结局
- 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)
研究者
Robert Edwards
Clinical Psychologist
Brigham and Women's Hospital