A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Score
研究概览
简要总结
Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group.
Compare adverse event profile in both groups
详细描述
Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections.
Single-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months.
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
- Double (Participant, Care Provider)
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
- •Over 18 years of age
- •History of chronic, function limiting low back pain of at least 6 months in duration
- •Able to give voluntary, written informed consent
- •Able to understand investigational procedures and willing to return for follow-ups
- •No recent surgical procedures within last 3 months
排除标准
- •Large contained or sequestered herniation
- •Cauda Equina symptoms and/or compressive radiculopathy
- •Narcotic use of no greater than 100mg/day Hydrocodone, 60mg Methadone, or 100mg Morphine
- •Uncontrolled major depression or psychiatric disorder
- •Uncontrolled or acute medical illness
- •Chronic sever conditions that could interfere with outcome assessments
- •Women who are pregnant or lactating
- •Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
结局指标
主要结局
Numeric Pain Rating Score
时间窗: 3, 6, 12, 18 and 24 months post treatment.
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable
次要结局
- Functional Status(3, 6, 12, 18 and 24 months post treatment.)
研究者
Laxmaiah Manchikanti, MD
Medical Director
Pain Management Center of Paducah