A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment
研究概览
简要总结
To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids.
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
To assess improvements among patients and compare steroid groups with each other and local anesthetic group.
To evaluate and compare the adverse event profile in all patients
详细描述
Patients with chronic low back pain of at least 6 months duration, non-responsive to conservative management with NSAIDS, physical therapy or chiropractic treatment exercises.
A single-center, prospective, controlled, double blinded, randomized study of patients in 4 groups.
- Group 1. local anesthetics only
- Group 2. local anesthetic with 6mg of non-particulate Celestone
- Group 3. local anesthetic with 6 mg of brand name Celestone
- Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
All patients will be unblinded in 12 months.
Non-responsive patients will be unblinded after 3 months and will be crossed over to a different 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
- 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
- •At least 18 years of age
- •History of chronic, function-limiting low back pain of at least 6 months duration
- •Able to give voluntary, written informed consent to participate,
- •Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up
- •No recent surgical procedures within last three months
排除标准
- •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 uncontrolled psychiatric disorder
- •Uncontrolled or acute medical illnesses
- •Chronic severe 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
- •Patients with multiple complaints involving concomitant hip osteoarthritis
- •Inability to achieve proper 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
研究组 & 干预措施
local anesthetic
Group 1. local anesthetics only
干预措施: Caudal epidural injection (Drug)
Local anesthetic with generic Celestone
Group 2. local anesthetic with 6mg of non-particulate Celestone
干预措施: Caudal Epidural Injection with generic Celestone (Drug)
Local anesthetic with Celestone
Group 3. local anesthetic with 6 mg of brand nameCelestone
干预措施: Caudal Epidural Injection with Celestone (Drug)
Local anesthetic with DepoMedrol
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
干预措施: Caudal Epidural Injection with DepoMedrol (Drug)
结局指标
主要结局
To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment
时间窗: 1,3,6,12 months
次要结局
- To assess adverse events in all four groups.(1,3,6,12 months)
研究者
Laxmaiah Manchikanti, MD
Medical Director
Pain Management Center of Paducah