Clavicle Splint for Pain Reduction After Posterior Cervicothoracic 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
- Average Neck Pain Level
研究概览
简要总结
The purpose of the study is to see whether a clavicle splint can decrease the pain after posterior cervicothoracic surgery. The term "cervicle splint" conveys that the investigators do not deal with clavicle fractures here but use the splint he stabilize the posterior cervical area. The investigators want to demonstrate this in a prospective randomized manner.
详细描述
In this prospectively controlled randomized study 30 patients who had undergone posterior cervical spine surgery were randomized into two groups who either wore or did not wear a clavicle brace to retract the shoulders. Patients in the brace group began wearing the brace on postoperative day 4, and continuously wore it throughout the 30-day study period. Outcome was measured as daily levels of self-reported pain and number of pain pills taken during the 30-day postoperative period. .
After hypothesizing a mean pain reduction through the brace on the visual analog scale (VAS) for pain from 5 to 3 with a standard deviation of 1, we calculated that at a power level of 99% and an alpha error of 5%, and given that the VAS numbers were normally distributed, we needed 22 patients to enroll into the study. We increased this number to 30 to account for early and late dropouts.
The study was performed at a single institution with patients from 2 different spine surgeons.
Patients were randomized prior to or the day after the procedure to either wear or not wear the clavicle brace. Randomization was done through closed envelopes that the patients drew. Dissection was performed by the two fellows at our institution and depended solely on the number of fused levels and whether or not a tumor had to be removed. Closure was also performed by the two spine fellows after instruction by the senior author. Cervical alignment was reviewed using the C2-C7 angle according to Cobb's method on lateral images. The cervico-thoracic angles were calculated by the addition of the cervical spine angle and the remaining angles of thoracic spine until T3 according to Cobb's method.
The brace was provided by the hospital. Patients were instructed how to properly wear the brace by the first author, the senior author, or the hospital Rehabilitation Orthotics specialist. To complete the study, patients wore the brace for at least 30 days. (Patients of J.P. continued to wear the brace for 3 months outside of the study period.). All patients wore hard cervical collars until the end of the study period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient underwent cervicothoracic surgery from posterior -
排除标准
- •Patients that are potentially vulnerable
结局指标
主要结局
Average Neck Pain Level
时间窗: 1 month
Patients self-recorded their average level of pain on a scale from 1 to 10 for each post-surgery day beginning on postoperative day 2. 1 Meaning least pain, 10 meaning worst level of pain
次要结局
未报告次要终点
研究者
Stephan Duetzmann
M.D.,M.Sc.
Stanford University
