Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 162
- 试验地点
- 26
- 主要终点
- Effectiveness of Treatment on Reduction of Back Pain Intensity
研究概览
简要总结
The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).
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
- •Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted
- •≥ 18 years of age at time of informed consent
- •Willing and available to attend visits as scheduled and to comply with the study protocol
- •Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
- •Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol
- •Diagnosed with FBSS (i.e.):
- •Has had persistent pain for 6 months following most recent anatomically correct, successful surgery AND
- •There are no further therapeutic surgical options available as assessed by appropriate investigation
- •Back pain is considered intractable and has been adequately treated (failed an appropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical))
- •Is an appropriate implant candidate for the SQS system
排除标准
- •Has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
- •Evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator
- •Has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator
- •Spinal instability or anatomic compression that requires further surgery
- •Spinal fusion at more than 3 vertebral levels
- •Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
- •Allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body
- •History of coagulation disorder or lupus erythematosus
- •Involved in current litigation regarding back pain
研究组 & 干预措施
SQS plus OMM
subcutaneous nerve stimulation plus optimized medical management
干预措施: subcutaneous nerve stimulation (Device)
SQS plus OMM
subcutaneous nerve stimulation plus optimized medical management
干预措施: Optimized Medical Management (Other)
OMM
optimized medical management
干预措施: Optimized Medical Management (Other)
结局指标
主要结局
Effectiveness of Treatment on Reduction of Back Pain Intensity
时间窗: 9 months
Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.
次要结局
- Average Change in Back Pain Intensity(6 and 9 months)
- Back Pain Responder Rate (≥50%) at 6 Months(6 months)
- Back Pain Responder Rate (≥30%) at 9 Months(9 months)