Pre-op CBT to Reduce the Risk for Development of Chronic Post-surgical Pain in Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 8
- 主要终点
- Preoperative Chronic Pain Severity
研究概览
简要总结
A significant number of patients develop chronic post-surgical pain (CPSP) following knee replacement surgery. Proposed is the testing of a novel computer-assisted behavioral intervention integrating motivational interviewing in the 4 weeks prior to surgery to address the risk factors for CPSP, with the expectation that severity of post-op pain and the incidence of CPSP will be reduced.
详细描述
A significant number of patients develop chronic post-surgical pain following knee joint replacement surgery, and the risk factors for this problematic outcome have been identified. Proposed is the development and preliminary efficacy testing of a novel computer-assisted cognitive behavioral intervention integrating motivational interviewing delivered in the four weeks prior to surgery to address these risk factors, with the expectation that both the severity of post-operative pain and the subsequent incidence of chronic post-surgical pain will be reduced. In that chronic post-surgical pain brings with it diminished functionality and quality of life, ongoing opioid use, and direct patient costs, it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting.
In a sample of adults over the age of 21 with chronic pain undergoing a planned TKA, the objectives of this randomized clinical trial are to:
- Add a motivational interviewing component to a validated computer-assisted CBT intervention for chronic pain (painTRAINER) to encourage opioid tapering, if applicable, and program adherence in the 4 weeks prior to surgery in patients scheduled to undergo a TKA.
- Describe the efficacy of the 4-week targeted pre-operative CBT intervention in 45 TKA patients to decrease preoperative chronic pain severity, preoperative opioid consumption, and symptoms of depression, anxiety and pain catastrophizing prior to surgery in comparison to 45 TKA patients randomized to treatment-as-usual.
- Describe the effects of a 4-week targeted pre-operative CBT intervention in 45 TKA patients on 48hr post-operative pain severity, and 3- and 6-month rates of CPSP in comparison to 45 TKA patients randomized to treatment-as-usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, age > 21 years
- •Chronic non-malignant pain of at least 3 months duration
- •Morphine equivalent daily dose (MEDD) > 40 milligrams for at least 3 months
- •Able to enroll at least 4 weeks prior to planned surgery
- •Able to speak, read and comprehend in English at the 6th grade or higher proficiency
排除标准
- •Pain of malignant origin
- •Current or past history of opioid use disorder (including those on medication-assisted therapy)
- •Revision of TKA
- •Comorbid CNS disease such as dementia, HIV, psychosis, poorly controlled bipolar disorder or any condition interfering with informed consent
结局指标
主要结局
Preoperative Chronic Pain Severity
时间窗: prior to surgery, approximately 6 weeks following baseline.
The severity of preoperative chronic pain will be evaluated with the Brief Pain Inventory (BPI), along two dimensions: intensity and interference. Pain intensity is rated on a 0 (no pain) to 10 (worst pain imaginable) scale as the worst in the past 24 hours, least in the past 24 hours, average pain and current pain. Pain interference is measured in 7 areas: general activity, mood, walking ability, work, sleep, enjoyment of life and relationships on a 0 (no interference) to 10 (interferes completely) scale. The composite mean of these scores are used as a pain interference score. BPI scores will be collected at baseline and compared to those collected just prior to surgery and at 3- and 6-month follow-up. Higher composite mean scores represent more pain interference (worse outcome).
次要结局
- Preoperative Opioid Use(prior to surgery, approximately 6 weeks following baseline)
- Post-operative Opioid Use(6-months)
- Pre-Op Depression(pre-operation, approximately 6 weeks following baseline)
- Post-Op Depression(6-months)
- Pre-Op Anxiety(pre-operation, approximately 6 weeks following baseline)
- Post-Op Anxiety(6-months)
- Pre-Op Catastrophizing(pre-operation, approximately 6 weeks following baseline)
- Post-Op Pain Severity(48 hours post-operatively)
- Chronic Post-Surgical Pain(6-months)
- Post-operative Chronic Pain Intensity(6-months)
研究者
Peggy Compton, RN, PhD
Associate Professor, van Ameringen Endowed Chair
University of Pennsylvania