NCT01158092终止不适用
A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for 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 5 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of cooled radiofrequency denervation of the sacroiliac region using the SInergy System compared to conservative treatment in the treatment of sacroiliac joint 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
- None
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
- •Predominantly axial pain below the L5 vertebrae
- •>75% pain relief from 2 separate lateral branch blocks done on different days (followed by return to baseline pain)
- •Chronic axial pain lasting for longer than six months: 3 day average VAS between 4 and
- •Age greater than 18 years.
- •Failed to achieve adequate improvement with comprehensive non-operative treatments, including but not limited to: activity alteration, non-steroidal anti-inflammatory, physical and/or manual therapy, and fluoroscopically guided steroid injections in and around the area of pathology.
- •All other possible sources of low back pain have been ruled out, including but not limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor and other regional soft tissue structures (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
排除标准
- •Beck Depression Score >20 or irreversible psychological barriers to recovery
- •Spinal pathology that may impede recovery such as spina bifida occulta, spondylolisthesis at L5/S1, or scoliosis.
- •Moderate or severe foraminal or central canal stenosis
- •Systemic infection or localized infection at anticipated introducer entry site.
- •Concomitant cervical or thoracic pain greater than 2/10 on a VAS
- •Uncontrolled or acute illness
- •Chronic severe conditions such as rheumatoid/inflammatory arthritis
- •Pregnancy
- •Active radicular pain
- •Immunosuppression (eg. AIDS, cancer, diabetes, surgery <3 months ago)
- •Worker's compensation, injury litigation, or disability remuneration
- •Allergy to injectants or medications used in procedure
- •High narcotics use (>30 mg hydrocodone or equivalent)
- •Patients who smoke. Termination for at least 6 months and no smoking during follow up period are acceptable with caution.
- •Body Mass Index greater than 29.9 (obese).
- •Subject unwilling to consent to the study
结局指标
主要结局
Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS)
时间窗: 12 months
次要结局
- Change in bodily pain evaluated using SF-36 Bodily Pain(12 months)
- Change in physical functioning evaluated using SF-36 Physical Function(12 months)
- Change in disability evaluated using Oswestry Disability Index 2.0(12 months)
- Change in quality of life using the Assessment of Quality of Life (AQOL)(12 months)
研究者
研究点 (2)
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