A Randomized Trial of an Early Postoperative Home Exercise Program Versus Usual Care After Anterior Cervical Discectomy and Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
The overall objective of this two-group randomized controlled trial is to gather preliminary evidence on the efficacy and safety of early postoperative exercise for improving disability, pain, and general physical health in patients after anterior cervical discectomy and fusion (ACDF) surgery. Our central hypothesis is that an early home exercise program (HEP) performed within the first six weeks after surgery will decrease disability and pain and improve general health, through increases in physical activity and self-efficacy and reductions in fear of movement. The results of our randomized trial will advance research on postoperative management for patients with cervical spine surgery and provide evidence in line with a value-based healthcare approach for optimizing outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical treatment of a cervical degenerative condition (cervical stenosis, spondylosis, degenerative spondylolisthesis, disc herniation) using anterior cervical discectomy and fusion procedure;
- •English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
- •Age older than 21 years (younger individuals do not typically have a cervical degenerative condition)
排除标准
- •Patients having surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
- •Patients undergoing cervical corpectomy;
- •Diagnosis or presence of severe psychiatric disorder such as schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder;
- •Documented history of alcohol and/or drug abuse;
- •Patients having surgery under a workman's compensation claim; and
- •Unable to provide a stable telephone or physical address
研究组 & 干预措施
Early Home Exercise Program
The early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery.
干预措施: Early Home Exercise Program (Behavioral)
Usual Care
Usual postoperative care.
干预措施: Usual Care (Other)
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: Up to 12 months after surgery
The NDI measures disease-specific disability for cervical spine patients.
Numeric Rating Scale (NRS)
时间窗: Up to 12 months after surgery
The NRS measures levels of neck and arm pain intensity.
12-Item Short Form Health Survey (SF-12)
时间窗: Up to 12 months after surgery
The SF-12 is a measure of general physical and mental health.
次要结局
- Movement Accelerometry(Up to 12 months after surgery)
研究者
Kristin Archer
Associate Professor and Vice Chair of Research
Vanderbilt University Medical Center