A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The number of patients with at least 50% improvement in VAS Pain Score
研究概览
简要总结
The investigators will be evaluating quality of life outcomes in patients who are undergoing routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre and post-operatively for quality of life improvements, pain control, and functionality.
详细描述
This is a prospective cohort study for patients who will be undergoing implantation of spinal cord stimulator for pain. All patient will have implantation done at University Hospital Newark or Newark Beth Israel. The data points that will be collected will be the patient's weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street, suite 8100. Those patients enrolled will have the same data taken again upon subsequent postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a well-documented safe procedure, the investigators do not anticipate any deviation from the standard risks of surgery. With that being said the primary safety endpoint would be if there is an increased complication rate, secondary to the procedure, greater than the current anticipated risk rate. This is a purely observational study. Patients are not being recruited for an intervention but are being recruited during routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with neuropathic pain or axial back pain that is not controlled by oral analgesics, opioids, and has failed conservative management.
- •Ages 18-90 with no ethnicity or gender predilections.
排除标准
- •Patients who have spinal cord injury, multiple stimulator revisions, DRG stimulators, intrathecal pain pumps, complex regional pain syndrome, previous spinal cord stimulator implant, mechanical instability requiring fusion, myelopathy, psychological condition precluding them from complying with therapy, illegal drug abuse including heroin, cocaine, and illegally obtained prescription pills, or have previously been or are currently involved in litigation for medical malpractice.
结局指标
主要结局
The number of patients with at least 50% improvement in VAS Pain Score
时间窗: 12 Months
The number of patients who had at least 50% improvement in VAS pain score
The number of patients with at least 50% improvement in Owenstry low back disability index
时间窗: 12 Months
The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
The number of patients with at least 50% improvement in WHODAS 12 disability index.
时间窗: 12 Months
The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
次要结局
- The number of patients with at least 50% improvement in SF-36 quality of life score(12 months)
- The number of patients with at least 50% improvement in beck depression inventory(12 Months)
研究者
Antonios Mammis MD
Director, Center for Neuromodulation
Rutgers, The State University of New Jersey