Surgical Recovery Support Pillow for Spine Surgeries
The present study investigates the feasibility of a support pillow for use after spinal surgical procedures, and more particularly, to protect the midline region of the back following spinal surgery.
Existing cushioning pillows do not accommodate the anatomy of the human back nor the requirements of isolating a vertical spinal incision. For example, donut-style or ring-shaped pillows are designed for entirely different purposes, such as hemorrhoidal relief, and cannot provide the desired spinal relief. As a result, there is no suitable, dedicated support structure that allows a patient to rest on their back while eliminating pressure on the surgical site. Accordingly, there is a need for a device that permits postoperative spinal surgery patients to sit or lie in a supine or reclined position without the surgical incision contacting or being compressed by any supporting surface.
研究概览
详细说明
The investigators hypothesize that use of the back saver pillow as currently designed will be feasible and that patients will report subjective improvement in pain when applying the pillow. Our specific aims are two-fold, namely (1) Determine if patients are able to utilize the back saver pillow as currently designed and (2) Survey patients as to whether they feel the back saver pillow was beneficial for their recovery.
Our study design is as follows. Eligible patients will be asked pre-op whether they would like to be part of this study and asked for informed consent prior to surgery. A total of 10 patients will be recruited. Enrolled patients will be provided with the back saver pillow either while admitted, if inpatient, or at the time of discharge for same-day surgery patients. Patients will be asked to fill out a survey with questions related to how easy the pillow was to use and whether they found it to reduce their pain on the rating scale of 1-10, where 1 is no pain and 10 is most painful. There will be 3 survey timepoints post-surgery: (1) on the day following surgery, (2) right before discharge and (3) 2-weeks post-surgery. Surveys will assess patient feedback about ease of use, and pain, first without the pillow in the supine position and sitting up with the back against another surface, then with the pillow in the supine position and sitting up with the back against another surface.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Pamela C Zuckerman, PhD
- 电话号码：13479201340
- 邮箱：pcabahugzu@montefiore.org
学习地点
-
-
New York
-
The Bronx、New York、美国、10461
- 招聘中
- Montefiore Medical Center
-
接触：
- Ananth C Eleswarapu, MD
- 电话号码：718-920-2060
- 邮箱：aeleswarap@montefiore.org
-
接触：
- Pamela C Zuckerman, PhD
- 电话号码：347-920-1340
- 邮箱：pcabahugzu@montefiore.org
-
首席研究员：
- Ananth Eleswarapu, MD
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adult patients who have lumbar fusion surgery, who consent to participate
Exclusion Criteria:
- Pediatric patients 18 years old and under
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Participant
Surgical Recovery Support Pillow
|
The Surgical Recovery Support Pillow for Spine Surgeries is a pillow with an open space in the middle in the shape of the spine.
The space can accommodate the healing of the surgical site wound by minimizing friction between pillow and spinal wound which can lead to disruption of the sutures and infections.
In contrast, normal pillows do not have a central open space in the shape of the spine, and does not minimize the wound friction.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pillow use
大体时间：One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
Pillow use will be measured as a dichotomous measure of whether or not the pillow was used.
Results will be summarized.
|
One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pillow comfort and pain
大体时间：One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery
|
Pillow comfort and pain will be assessed as a single composite measure on a scale from 1 to 10, with 1 being very little pain and 10 being extremely painful, such that higher scores are indicative of increased pain.
Assessments will be made both without the back saver pillow - in both the supine position and sitting up with back against another surface, and with the back saver pillow - in both the supine position and sitting up with back against another surface.
Results for each combination of pillow set up will be summarized using descriptive statistics.
|
One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of pillow usage
大体时间：One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
For participants who used the pillow, frequency of pillow usage since it was administered will be summarized using the following ordinal variables: (1) Never (2) Sometimes or (3) All the time.
Results will be summarized using descriptive statistics.
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One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
合作者和调查者
调查人员
- 首席研究员：Ananth Eleswarapu, MD、Montefiore Medical Center
出版物和有用的链接
一般刊物
- Ghobrial GM, Harrop JS, Sasso RC, Tannoury CA, Tannoury T, Smith ZA, Hsu WK, Arnold PM, Fehlings MG, Mroz TE, De Giacomo AF, Jobse BC, Rahman RK, Thompson SE, Riew KD. Anterior Cervical Infection: Presentation and Incidence of an Uncommon Postoperative Complication. Global Spine J. 2017 Apr;7(1 Suppl):12S-16S. doi: 10.1177/2192568216687546. Epub 2017 Apr 1.
- Chaichana KL, Bydon M, Santiago-Dieppa DR, Hwang L, McLoughlin G, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham T. Risk of infection following posterior instrumented lumbar fusion for degenerative spine disease in 817 consecutive cases. J Neurosurg Spine. 2014 Jan;20(1):45-52. doi: 10.3171/2013.10.SPINE1364. Epub 2013 Nov 8.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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