Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 28
- 主要终点
- Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
研究概览
简要总结
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).
详细描述
The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:
- SCS group (SCS+OMM)
- OMM group
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCS candidate with the Specify 5-6-5 surgical lead
- •Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
- •Average low back pain is ≥ 5 as assessed by the baseline NPRS
- •Average low back pain is greater than leg pain
- •Subject has persistent moderate to severe low back and leg pain despite other treatments
排除标准
- •Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
- •Most recent back surgery < 6 months ago
- •Low back pain only (no leg pain)
- •Investigator suspects substance abuse that might confound the study results
- •Radiographic evidence of instability requiring fusion
- •Pain relieved completely by lying down
- •Life expectancy of < 24 months
- •Subject is pregnant or planning to become pregnant during the course of the study
- •Subject is unable to undergo study assessments or complete questionnaires independently
研究组 & 干预措施
SCS + OMM
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
干预措施: Spinal Cord Stimulation (SCS) (Device)
SCS + OMM
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
干预措施: Optimal Medical Management (OMM) (Drug)
OMM alone
The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan
干预措施: Optimal Medical Management (OMM) (Drug)
结局指标
主要结局
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
时间窗: 6 months post randomization
Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.
次要结局
- Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups(6 months post randomization)
- Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups(6 months post randomization)
- Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups(6 months post randomization)
- Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups(6 months post randomization)