NCT00681447已完成不适用
A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain
适应症
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
- To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.
研究概览
简要总结
- To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
- To evaluate and compare the adverse event profile in all patients.
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
- 否
入选标准
- •Subjects of at least 18 years of age
- •Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
- •Subjects who are able to give voluntary, written informed consent to participate in this investigation
- •Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
- •Subjects have not had recent surgical procedures within the last 3 months.
排除标准
- •Cauda Equina symptoms and/or compressive radiculopathy
- •Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
- •Uncontrolled major depression or uncontrolled psychiatric disorders
- •Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
- •Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
- •Women who are pregnant or lactating
- •Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
- •Patients with multiple complaints involving concomitant hip osteoarthritis, due to the overlap of pain complaints
- •Inability to achieve appropriate positioning and inability to understand informed consent and protocol
- •History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
- •Previous surgery.
结局指标
主要结局
To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.
时间窗: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
次要结局
- To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.(Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.)
- To evaluate and compare the adverse event profile in all patients.(Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.)
研究者
Laxmaiah Manchikanti, MD
Medical Director
Pain Management Center of Paducah
研究点 (2)
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