Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 9
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
研究概览
简要总结
Patients undergoing knee replacement surgery and who have high levels of pain catastrophizing are at risk for poor outcome. The clinical trial is designed to determine if a pain coping skills training intervention delivered by physical therapists and supervised by psychologists is more effective at reducing pain and improving function and is more cost effective than arthritis education or usual care.
详细描述
Approximately 25% of patients following knee arthroplasty have disabling pain following apparently successful surgery. Recent research suggests that pain catastrophizing plays a key role in determining which patients with knee arthroplasty have a poor outcome. In addition to this evidence, a substantial literature suggests that pain coping skills training is effective for patients with chronic pain but the intervention has not been studied for surgical patients with severe arthritic knee pain. We designed the Knee Arthroplasty pain coping Skills Training (KASTPain) trial to address this research need. This Phase III three-arm randomized clinical trial seeks to combine a strong and diverse group of researchers to examine an important and understudied area in the joint arthroplasty literature. The KASTPain trial will be the first to examine the utility of a perioperative pain coping intervention for this substantial population of patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 45 years and older and capable of providing informed consent
- •Diagnosis of osteoarthritis as determined by participating orthopaedic surgeons
- •Scheduled for an elective unilateral total or unicompartmental knee arthroplasty no sooner than 1 week and no later than 8 weeks from the time of recruitment
- •Score of greater than or = to 16 on the Pain Catastrophizing Scale
- •Score of greater than or = to 5 on the WOMAC Pain Scale
- •Able to read and speak English
排除标准
- •Scheduled for revision arthroplasty surgery
- •Underwent contralateral knee arthroplasty surgery or hip arthroplasty surgery within 6 months of currently planned surgery
- •Unable to or declines study participation
- •Self-reported diagnosis of rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, ankylosing spondylitis
- •Arthroplasty surgery scheduled because of fracture, malignancy or infection
- •Scheduled for bilateral arthroplasty surgery
- •Scheduled to undergo hip or knee arthroplasty within 6 months of current knee arthroplasty
- •Score of 20 or greater on the PHQ-8 depression scale
- •Score of less than 3 on the six-item cognitive screener
研究组 & 干预措施
Pain Coping Skills Training
The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.
干预措施: Pain Coping Skills Training (Behavioral)
Arthritis Education
The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.
干预措施: Arthritis Education (Behavioral)
Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
干预措施: Usual Care (Other)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
时间窗: twelve months
A self report scale that quantifies the extent of function limiting pain. The scale ranges from 0 to 20 with higher scores denoting worse activity related pain.
次要结局
- Six-minute Walk Test(twelve months)
- 0 to 10 Verbal Pain Rating Scale(twelve months)
- WOMAC Physical Function Scale(twelve months)
- Pain Catastrophizing Scale(twelve months)
- Global Rating of Change Scale(twelve months)
- Short Physical Performance Battery(twelve months)