Cognitive Behavioral Therapy to Optimize Post-Operative Recovery (COPE): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,024
- 试验地点
- 17
- 主要终点
- The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture
研究概览
简要总结
Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture in patients with an open or closed fracture of the appendicular skeleton, treated with internal fixation.
详细描述
The relationship between psychological factors, behaviors, and cognitive processes and the sensation of pain is well documented. Stress, distress, anxiety, depression, catastrophizing, fear-avoidance behaviors, and poor coping strategies appear to have a significant positive relationship with both acute and chronic pain. Evidence suggests that these psychological factors can cause alterations along the spinal and supraspinal pain pathways which influence the perception of pain. Previous studies suggest that patients' beliefs and expectations may be associated with clinical outcomes, including self-reported pain. Previous studies in trauma patients have demonstrated patients' beliefs and expectations regarding their recovery following surgery are associated with functional limitations, lower rates of return to work, and reduced quality of life one year after injury. Furthermore, up to two thirds of patients with operative managed extremity fractures demonstrate unhelpful illness beliefs that increase risks of negative outcomes, including persistent pain. Psychological interventions, such as cognitive behavioural therapy (CBT), that are designed to modify unhelpful beliefs and behaviours have the potential to reduce persistent post-surgical pain and its associated effects among trauma patients.
Our primary objective is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe PPSP over 12 months post-fracture in participants with an open or closed fracture of the appendicular skeleton. Our secondary objectives are to determine if CBT, versus usual care: 1) increases physical functioning, 2) improves mental functioning, 3) accelerates return to function, 4) reduces pain severity, and 5) reduces pain interference over 12 months post-fracture, and 6) reduces the proportion of participants prescribed opioid class medications at 6 and 12 months post-fracture. This trial is a multi-centre randomized controlled trial (RCT) of 1,000 participants with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis treated with internal fixation.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women aged 18 years and older.
- •Presenting to fracture clinic within 2-12 weeks following an acute open or closed fracture of the appendicular skeleton. Patients with multiple fractures may be included.
- •Fracture treated operatively with internal fixation.
- •Willing to participate in CBT.
- •Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel).
- •Consistent access to a smart phone and/or tablet that is capable of running the CBT provider's application.
- •Provision of informed consent.
排除标准
- •Fragility fracture.
- •Stress fracture.
- •Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture.
- •Among patients who are fully weightbearing, those not experiencing any pain in the fracture region.
- •Active psychosis.
- •Active suicidality.
- •Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the trial.
- •Already participating in, or planning to, start other psychological treatments (including CBT) within the duration of the study (12 months).
- •Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up.
- •Incarceration.
- •Currently enrolled in a study that does not permit co-enrolment in other trials.
- •Previously enrolled in the COPE trial.
- •Other reason to exclude the patient, as approved by the Methods Centre.
结局指标
主要结局
The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture
时间窗: 12 months post-fracture
The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition. The WHO's definition requires 4 criteria for the diagnosis of PPSP: 1) Pain that began after surgery or a tissue trauma is experienced; 2) The pain is in an area of preceding surgery or tissue trauma, 3) The pain persisted for at least three months after the initiating event, and 4) The pain is not better explained by an infection, a malignancy, a pre-existing pain condition or any other alternative cause.
次要结局
- Short Form 36 (SF-36)(12 months post-fracture)
- Return to Function Questionnaire(12 months post-fracture)
- Opioid Use(12 months post-fracture)
- Brief Pain Inventory-Short Form (BPI-SF)(12 months post-fracture)