ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 53
- 主要终点
- Change in Oswestry Disability Index (ODI)
研究概览
简要总结
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
详细描述
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years
- •Evidence of lumbar multifidus muscle dysfunction
- •Intractable Chronic Low Back Pain that has persisted >6 months resulting in pain most of the days in the past 12 months
- •Failed therapy including pain medications and physical therapy
- •Not a candidate for spine surgery
- •Low Back Pain NRS of ≥6 and ≤9
- •Oswestry Disability Index score ≥30 and ≤60
- •Willing and capable of giving Informed Consent
- •Able to comply with this protocol
- •On Optimal Medical Management per the Investigator
排除标准
- •Contraindicated for the ReActiv8 System
- •Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
- •An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery
- •Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee
- •Any condition unrelated to CLBP which, in the opinion of the Investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy
- •Surgical and other procedure exclusions
- •Psycho-social exclusions
- •Protocol compliance exclusions
- •General exclusions
研究组 & 干预措施
Treatment (ReActiv8)
Market-approved ReActiv8 device
干预措施: ReActiv8 (Device)
Control (OMM)
Optimized medical management (OMM) (Standard of Care)
结局指标
主要结局
Change in Oswestry Disability Index (ODI)
时间窗: 1 year
Comparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data. ODI is measured on a scale of 0 to 100 where a lower score is a better outcome.
次要结局
- Change in Low Back Pain Numerical Rating Scale (LBP NRS)(1 year)
- Change in EQ-5D(1 year)