MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 12
- 主要终点
- Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
研究概览
简要总结
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years or older and a Medicare beneficiary.
- •Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
- •LSS with neurogenic claudication diagnosed via:
- •Symptomatic diagnosis and
- •Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum >2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.
- •Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
- •Available to complete 6 month and one year follow-up visits.
排除标准
- •ODI Score < 31 (0-100 ODI Scale).
- •NPRS Score < 5 (0-10 NPRS Scale).
- •Prior surgery at any treatment level.
- •History of recent spinal fractures with current related pain symptoms.
- •Patients with Grade III or higher spondylolisthesis.
- •Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
- •Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.
- •Patients previously randomized and/or treated in this clinical study.
- •Patients that have previously received the MILD procedure.
- •ESI during eight weeks prior to study enrollment.
- •Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
- •On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
研究组 & 干预措施
MILD
The MILD procedure is an image-guided minimally-invasive lumbar decompression
干预措施: MILD Procedure (Procedure)
Epidural Steroid Injection (ESI)
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
干预措施: Epidural Steroid Injection (Drug)
结局指标
主要结局
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
时间窗: 12 months
Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.
次要结局
- Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months(12 months)
- Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months(12 months)