Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 4
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
The overall objective of this study is to conduct a two-group randomized control trial (RCT) to compare which of two treatments provided by telephone - a cognitive-behavioral based physical therapy (CBPT) program focusing on self-management strategies or an education program about postoperative recovery - are more effective for improving patient-centered outcomes in older adults recovering from lumbar spine surgery for degenerative conditions. Our central hypothesis is that the CBPT intervention focusing on self-management will decrease pain and disability and improve general health, physical activity and physical function in community-dwelling adults undergoing spine surgery, through reductions in fear of movement and increases in pain self-efficacy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes
- •Surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis procedures
- •English speaking due to feasibility of employing study personnel to deliver and assess the study intervention
- •Age older than 21 years (younger individuals do not typically have a lumbar degenerative condition).
排除标准
- •Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or laminectomy without arthrodesis)
- •Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion population)
- •Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- •Presence of back and/or lower extremity pain < 3 months indicating no history of chronic pain
- •History of neurological disorder or disease, resulting in moderate to severe movement dysfunction. Including but not limited to Parkinson's disease, Multiple Sclerosis, Epilepsy, Brain tumors, Huntington's disease, Alzheimer's disease, Muscular Dystrophy, Stroke, Autonomic Nervous System disorders, Traumatic Brain Injury, Cerebral Palsy, and Amyotrophic Lateral Sclerosis
- •Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder
- •Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel limitation
- •Patients having surgery under a workman's compensation claim
- •Unable to provide a stable address and access to a telephone indicating the inability to participate in either the telephone-based CBPT or education program.
研究组 & 干预措施
CBPT intervention
CBPT program consisting of weekly phone calls.
干预措施: CBPT (Behavioral)
Education intervention
Education program consisting of weekly phone calls.
干预措施: Education (Other)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Up to 12 months.
The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.
12-Item Short Form Health Survey (SF-12)
时间窗: Up to 12 months after spine surgery
The SF-12 is a measure of general physical and mental health. The SF-12 is scored from 0 to 100, with higher scores indicating better health.
Brief Pain Inventory (BPI)
时间窗: Up to 12 months after spine surgery
The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome
次要结局
- Physical Activity(Up to 12 months after spine surgery)
研究者
Kristin Archer
Associate Professor
Vanderbilt University Medical Center