ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 27
- 主要终点
- Mean Change in Low Back Pain VAS
研究概览
简要总结
The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥22 years, ≤75 years
- •Chronic Low Back Pain that has persisted >90 days prior to the baseline visit.
- •Continuing low back pain despite >90 days of medical management.
- •Qualifying pain score.
- •Qualifying disability score.
- •Evidence of lumbar multifidus muscle dysfunction.
- •Be willing and capable of giving Informed Consent.
- •Ability to comply with the instructions for use and to operate ReActiv8, and to comply with this Clinical Investigation Plan.
- •Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
排除标准
- •Back Pain characteristics:
- •Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
- •Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in subjects with lower extremity pain.
- •Neurological deficit possibly associated with the back pain (e.g. foot drop).
- •Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
- •Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia).
- •Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amenable to surgery.
- •Back pain due to vascular causes such as aortic aneurysm and dissection.
- •Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
- •Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
- •Source of pain is the sacroiliac joint as determined by the Investigator.
- •Surgical and other procedures exclusions.
- •Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion that is amenable to surgery.
- •Planned surgery.
- •Co-morbid chronic pain conditions.
- •Other clinical conditions.
- •Psycho-social exclusions.
- •Protocol compliance exclusions.
- •General exclusions.
结局指标
主要结局
Mean Change in Low Back Pain VAS
时间窗: 120 Days
Comparison of change in LBP VAS (120 days from baseline) between the Treatment and Control groups. The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, where zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain. A change to a lower score (negative value) indicates improvement.
Responder Rate of Low Back Pain With No Increase in Pain Medications
时间窗: 120 Days
Comparison of responder rates for low back pain VAS between Treatment and Control groups. The Primary Efficacy Endpoint is a comparison of responder rates between Treatment and Control groups, where a "responder" is a participant with ≥30% reduction from baseline in average low back pain VAS, without any increase from baseline in pain medications and/or muscle relaxants for any reason including non low back pain reasons. The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, where zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain. Any increase in dosage of a pain medication or any new pain medication taken for any reason counts as an increase in medications.
Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels
时间窗: 120 Days
The CPRA, which was prespecified in the clinical protocol and statistical analysis plan prior to the start of the trial, was performed using the same data as used for the primary endpoint analysis and was included as part of the primary endpoint analysis
Serious Device and/or Procedure Related Adverse Event Rate
时间窗: 120 Days
The primary safety assessment is of serious device and/or procedure related adverse events in all participants at 120 days. The 8 events reported below are 6 implant site pocket infections, 1 intra-operative upper airway obstruction, and 1 non-radicular, focal numbness on the surface of the thigh.
次要结局
- Percent Pain Relief at One Year(1 Year)
- Change in Oswestry Disability Index (ODI)(120 Days)
- LBP VAS Responder Rate at One Year(1 Year)
- Change in Oswestry Disability Index (ODI) at One Year(1 Year)
- Change in European Quality of Life Score on Five Dimensions (EQ-5D)(120 Days)
- Change in Percent Pain Relief (PPR)(120 Days)
- Subject Global Impression of Change (SGIC)(120 Days)
- Resolution of Back Pain (VAS ≤2.5 cm)(120 Days)
- Mean Change in LBP VAS at One Year(1 Year)
- Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year(1 Year)
- Subject Global Impression of Change (SGIC) at One Year(1 Year)
- Resolution of Back Pain at One Year(1 Year)