NCT00749554终止4 期
Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin
Baylis Medical Company2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).
研究概览
简要总结
The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Able to understand the informed consent and baseline/follow-up questionnaires
- •Chronic low back pain > leg pain for longer than 6 months, unresponsive to comprehensive non-operative treatment
- •No clinical evidence of SI joint mediated pain
- •Concordant pain reproduced on provocative discography at an intensity of >6/10 at low pressure (<50 psi) at not more than 2 discs and a negative response at an adjacent control disc
- •Preservation of at least 50% height of the symptomatic disc(s)
排除标准
- •Active radicular pain
- •Nucleus pulposus herniation > 5 mm, extrusion or sequestration on MRI
- •Spondylolithesis at the symptomatic level
- •Prior surgery at the symptomatic level
- •Concomitant cervical or thoracic pain >2/10 (VAS) in severity
- •Other chronic pain conditions (i.e. Fibromyalgia Syndrome)
- •Immunosuppression (i.e. Cancer, AIDS, Rheumatoid arthritis)
- •Third-party (WSIB, litigation or insurance) involvement
- •Psychological issues impeding recovery by history, examination and/or a Beck Depression Inventory score of >20
- •Systemic or localized infection (at the anticipated needle entry sites)
- •BMI > 35 (Obesity)
- •Substance or opioid abuse
- •Coagulopathy
结局指标
主要结局
Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).
时间窗: 12 months
次要结局
- Oswestry Disability Index(12 months)
- Assessment of Quality of Life(12 months)
- SF-36 for physical functioning(12 months)
- Reduction in Medication Intake(12 months)
- Patient satisfaction(12 months)
研究者
研究点 (2)
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