NCT01985230已完成不适用
Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain
Mainstay Medical17 个研究点 分布在 3 个国家目标入组 96 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 17
- 主要终点
- Number of subjects with Adverse Events
研究概览
简要总结
The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, ≤65 years
- •Chronic Low Back Pain with a first occurrence >90 days prior to enrolment, and the last relatively pain-free time >90 days prior to enrolment.
- •Continuing low back pain despite >90 days of medical management
- •Oswestry Disability Index score ≥25% and ≤60% at the time of enrolment
- •Able to understand and sign the Informed Consent form.
- •Ability to comply with the instructions for use and to operate the ReActiv8, and to comply with this Clinical Investigation Plan.
- •Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
- •Prior week average Low Back Pain NRS of ≥6.0 and ≤9.0 on a 11 point NRS scale (0-10) at the Baseline Visit
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)
- •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
- •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
Number of subjects with Adverse Events
时间窗: 90 days, 12 months
11 Point Numerical Rating Scale (NRS) for Low Back Pain
时间窗: 90 days
次要结局
- Oswestry Disability Index(90 days)
研究者
研究点 (17)
Loading locations...
相似试验
终止
1 期
Deep Brain Stimulation in Treatment Refractory DepressionMajor Depressive DisorderNCT01921543Universitaire Ziekenhuizen KU Leuven7
已完成
不适用
Electrical Stimulation in Women With Pelvic Organ ProlapsePelvic Organ ProlapseNCT04733885KTO Karatay University26
进行中（未招募）
不适用
Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord InjuryTetraplegiaSpinal Cord InjuryNCT00583804MetroHealth Medical Center10
尚未招募
不适用
A study for clinical effect of electrical stimulatiolocomotive syndromeJPRN-UMIN000015693Saitama Medical University department of orthopaedic surgery200
Unknown
不适用
Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)Complex Regional Pain Syndrome Type I of the Upper LimbNCT01915329Ruhr University of Bochum50