A Randomized, Prospective, Double-Blind, Equivalence, Controlled Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis With or Without Steroids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work
研究概览
简要总结
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 evaluate and compare the adverse event profile in all patients.
详细描述
Recruitment is indicated in patients with chronic low back and lower extremity pain secondary to lumbar disc herniation and/or lumbar radiculitis of at least 6-months duration, non-responsive to conservative management with NSAIDs, physical therapy, chiropractic treatment, and exercises.
This is a single center study performed in an interventional pain management referral center in the United States.
The study involves 120 patients studied in 2 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding.
Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value < 0.05.
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
- •Patients with disc herniation or radiculitis
- •Patients who are 18 years of age
- •Patients with a history of chronic function-limiting low back and lower extremity pain of at least 6 months duration
- •Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements
排除标准
- •Previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation
- •Uncontrollable or unstable opioid use
- •Uncontrolled psychiatric disorders
- •Uncontrolled medical illness either acute or chronic
- •Any conditions that could interfere with the interpretation of the outcome assessments
- •Pregnant or lactating women
研究组 & 干预措施
Without Steroids
Group I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25%
干预措施: lumbar transforaminal epidural injections (Procedure)
steroids
Group II patients will receive lumbar transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level
干预措施: lumbar transforaminal epidural injections (Procedure)
结局指标
主要结局
Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work
时间窗: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
次要结局
- Adverse event profile of side effects and complications.(Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected.)
研究者
Laxmaiah Manchikanti, MD
Medical Director
Pain Management Center of Paducah