Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Disability
研究概览
简要总结
The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery.
The main question this clinical trial aims to answer are:
- Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants.
- Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes.
Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.
详细描述
This study is a prospective randomized controlled trial of early PT (within 3 months after surgery) versus delayed PT (greater than 3 months after surgery) in adults following ACDF surgery for degenerative conditions. The central hypothesis is that an early PT program will be effective in improving disability, pain, physical function, opioid use and return to work/duty. 76 participants will be enrolled and randomized (38 patients per randomized group), with 64 (85%) expected to be retained in the trial at the 12-month follow-up. Eligible patients undergoing ACDF surgery for a degenerative condition will be randomized to one of two groups (early PT or delayed PT). Patients will be enrolled prior to surgery, asked to complete a preoperative questionnaire prior to surgery and then randomized. Patients randomized to one of the PT groups will have their first PT visit scheduled for them by study staff prior to surgery. This visit will occur at approximately 2 weeks after hospital discharge for the early PT group and approximately 3 months after hospital discharge for the delayed PT group. All randomized patients will be asked to participate in follow-up visits approximately 3-, 6- and 12-months after hospital discharge.
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
- 18 Years 至 75 Years（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 using a 1- or 2-level ACDF procedure;
- •English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
- •Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)
排除标准
- •Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
- •Undergoing cervical corpectomy;
- •Prior history of cervical spine surgery in last 5 years;
- •Diagnosis or presence of osteoporosis;
- •Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
- •Documented history of alcohol and/or drug abuse;
- •Currently involved in litigation due to injury;
- •Currently undergoing treatment for cancer;
- •Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and
- •Unable to provide a stable telephone or physical address
研究组 & 干预措施
Early Physical Therapy (PT)
PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 2 weeks after hospital discharge
干预措施: Early PT (Other)
Delayed Physical Therapy (PT)
PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 3 months after hospital discharge.
干预措施: Delayed PT (Other)
结局指标
主要结局
Disability
时间窗: 6 and 12 months after hospital discharge
Neck Disability Index, 0-100 with higher scores indicating increased disability
次要结局
- Pain Intensity(6 and 12 months after hospital discharge)
- Physical Function(6 and 12 months after hospital discharge)
- Opioid Utilization(6 and 12 months after hospital discharge)
- Return to work(6 and 12 months after hospital discharge)
- Pain Interference(6 and 12 months after hospital discharge)
研究者
Kristin Archer
Professor and Vice Chair
Vanderbilt University Medical Center