NCT00802997已完成不适用
A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System
Baylis Medical Company2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2008年6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
- 51
- 试验地点
- 2
- 主要终点
- Pain Status Change for Sacroiliac Joint Pain Intensity
研究概览
简要总结
to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo 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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Predominantly axial pain below L5 vertebrae
- •greater than 75%pain relief from 2 seperate lateral branch blocks done on different days
- •chronic axial pain lasting longer than 6 months, 3 day average VAS between 4 and 8
- •age greater than 18
- •failed to acheive adequate improvemnet with comprehensive non-operative treatments, includingbut not limited to: activity alteration, non0steriodal anti-iflammatory, physical and/or manual therap, and flurpscopically guided steriod injections in and around the area of pathology
- •all other possible sources oflow back pain have been ruled out, including but not limited to the intervertebral discs, bone fracture.
排除标准
- •Beck Depression greater than 20%
- •irreversible psychological barriers to recovery
- •spinal pathology that may impede recovery such as spins bifida occulta,
- •moderate to severe foraminal or central canal stenosis
- •systemic infection or localized infection at inducer site
- •concomitant cervical or thoracic pain greater than 2/10 on VAS
- •uncontrolled or acute disease
- •chronic severe condition such as rheumatoid arthritis
- •preganancy
- •active radicular pain
- •immunosuppression
- •workers compensation
- •allergy to injectants or medications used in procedure
- •high narcotis use greater than 30 mg hydrocodone or equivalent
- •body mass index greater than 29.9
结局指标
主要结局
Pain Status Change for Sacroiliac Joint Pain Intensity
时间窗: Baseline and 3 months
Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
次要结局
未报告次要终点
研究者
研究点 (2)
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