Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- (Aim 1) Pain Catastrophizing Scale (PCS)
研究概览
简要总结
The investigators propose a randomized controlled trial to evaluate the effects of treatment intended to reduce pain catastrophizing among patients reporting high pain catastrophizing prior to total knee replacement(TKR), total hip replacement(THR), or shoulder surgery in an effort to thereby reduce the incidence of persistent post-surgical pain (PPP) and enhance physical function at 3-months post-surgery. Preemptive treatment aimed at a known predictor of PPP following total knee replacement is highly innovative and have potentially high impact for public health. Cognitive therapy is a well-tolerated modality among chronic pain patients with few if any side effects. Cognitive therapy (CT) represents an inexpensive method that could greatly reduce suffering and costly post-surgical pain management for high risk TKR patients.
详细描述
Aim 1 is to determine which CT protocol is most effective in reducing Pain Catastrophizing Scale (PCS) and Coping Strategies Questionnaire Catastrophizing Subscale (CSQ-CAT) scores in high-risk TKR candidates. CT will consist of four-to-eight weekly 1-hr individual cognitive therapy sessions prior to surgery.
Aim 2 is to compare the most efficient treatment from Aim 1 with a control group to evaluate pain relief at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing standard primary TKR; THR or Shoulder Surgery
- •18- 85 yrs of age;
- •Surgical joint is the primary source of patient's pain;
- •Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
- •Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
- •Patient has been diagnosed with osteoarthritis.
排除标准
- •Currently using antidepressant medication or undergoing cognitive therapy;
- •chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use > 4 wks;
- •history of opioid abuse;
- •inability to understand and communicate with the investigators to complete the study related questionnaires
- •patient is planning to undergo another elective joint procedure during the 6-mo period of participation;
- •any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification > 3}.
结局指标
主要结局
(Aim 1) Pain Catastrophizing Scale (PCS)
时间窗: 4 or 8 weeks after start of treatment
Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable.
(Aim 2) Proportion of patients with pain relief
时间窗: 3 month
Proportion of patients w a 3 month decrease in WOMAC pain subscale \<= 4. (WOMAC Osteoarthritis Index)
次要结局
- Patient Health Questionnaire (PHQ-8)(4 and 8 weeks after start of treatment)
- Generalized anxiety disorder (GAD-7)(4 and 8 weeks after start of treatment)
研究者
Asokumar Buvanendran
Profesor Anesthesiology
Rush University Medical Center