Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back/Radicular Leg Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Primary Effectiveness
研究概览
简要总结
This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain.
详细描述
This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain. This study will enroll 40 evaluable subjects and follow them for 60 days.
- Investigate the safety and feasibility of the Discogen device to alleviate back/radicular leg pain
- Assess the mean reduction in back and radicular leg pain following Discogen treatment.
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Primary Safety - collection of all adverse events, including any device- or procedure-related adverse events
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Primary Effectiveness -percent change from baseline for Numerical Pain Scale (NPS) radicular leg pain at 30 and 60 days. The scale ranges from 0(No pain) to 10 (Severe pain).
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Secondary Effectiveness:
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Change from baseline in Oswestry Disability Index at 30 and 60 days. The Index ranges from 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippled), to 81-100% (bed bound).
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Percent change from baseline NPS back pain at 30 and 60 days
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject may be included in the study if the following conditions are met:
- •Adult (> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits
- •Able and willing to complete study forms and communicate with the investigator
- •Presenting with unilateral radicular leg pain with or without axial back pain of >1 month duration
- •No epidural injections at treatment site within the last three months
- •Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)
- •Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1
- •MRI lumbar spine negative for extruded disc herniation, tumor, or bleeding, but positive for disc disease/herniation at L3-4, L4-5 or L5-S1 with mild to moderate foraminal or spinal stenosis (less than 50%).
排除标准
- •Pregnant or breastfeeding patient
- •Younger than 21 or older than 75 years
- •Presenting with motor deficits
- •Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse)
- •Presence of metal hardware within the lumbosacral spine
- •History of spine surgery at the level of treatment.
- •Lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse events (per the discretion of the study PI)
- •Severe lumbar central canal stenosis (greater than 50%)
- •Severe lumbar foraminal stenosis (greater than 50%)
- •Severe herniated lumbar disc 4(Grade 2 and above)
- •Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis
- •Unable to understand and complete research questionnaires
- •Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes.
- •BMI greater than 30
- •Implanted spinal stimulators
- •Epidural injections at treatment site within the last three months
研究组 & 干预措施
Treatment Group
Study subjects in the treatment group (Arm 1) will receive 3 daily Discogen treatments unilaterally within a one week (M-M) period, each lasting 25 minutes.
干预措施: Discogen Low pulsed ultrasound treatment (Device)
Sham Control Group
Subjects in the sham control arm (Arm 2) will receive 3 daily non-powered treatments unilaterally within a one week (M-M) period, each lasting 25 minutes
干预措施: Discogen Sham Treatment (Device)
结局指标
主要结局
Primary Effectiveness
时间窗: 30 and 60 days.
Percent change from baseline for Numerical Pain Scale (NPS) radicular leg pain at 30 and 60 days. The NPS is a patient-reported assessment of pain intensity, ranging from 0 (No pain) to 10 (Severe pain).
Primary Safety
时间窗: 60 days
Collection of all adverse events, including any device or procedure-related adverse events.
次要结局
- Change from baseline in Oswestry Disability Index(30 and 60 days.)
- Numerical Pain Scale (NPS)(30 and 60 days.)
研究者
Clark Smith
Associate Professor of Rehabilitation and Regenerative Medicine
Columbia University