Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Pain
研究概览
简要总结
Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. Patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using FAD compared to similar disc level identification by PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21 to 65 years.
- •Symptoms of at least 6 months duration.
- •Primarily axial low back pain.
- •At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc.
- •Patients with overall pain scores of greater than 6/10 (NRS).
- •Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level.
排除标准
- •History of previous spine surgery.
- •MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI.
- •Clinical or radiological evidence of significant:
- •Disc herniation
- •Spinal Stenosis
- •Spinal Deformity
- •Spondylolisthesis
- •Spinal instability or pars-defect
- •Facet Syndrome
- •Sacroiliac Joint Dysfunction
- •Myofascial Pain Syndrome
- •Fibromyalgia
- •Current issues of:
- •Drug addiction or substance abuse
- •Chronic pain medication abuse
- •Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.
结局指标
主要结局
Pain
时间窗: One Year
Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity) Standard Morphine Equivalent intake
次要结局
- Patient Satisfaction(One Year)
- Physical functioning(One Year)
- Quality of Life(One Year)