Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial
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)
研究概览
简要总结
The purpose of this study is to:
- evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections.
- evaluate and compare the adverse event profile in all groups.
详细描述
Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.
This is a single-center study performed in an interventional pain management referral center in the United States.
The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.
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 history of lumbar surgery of at least 6 months duration in the past
- •Patients over the 18 years of age
- •Patients with a history of chronic function-limiting low back pain with or without 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
- •Post surgery, central spinal stenosis, and facet joints as sole pain generators
- •Unstable or heavy opioid use
- •Uncontrolled psychiatric disorders
- •Uncontrolled medical illness
- •Any conditions that could interfere with the interpretation of the outcome assessments
- •Pregnant or lactating women
- •Patients with a history or potential for adverse reaction(s) to local anesthetics or steroid.
研究组 & 干预措施
Caudal epidural Injection
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
干预措施: Caudal Epidural Injection (Procedure)
Percutaneous Adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
干预措施: percutaneous adhesiolysis (Procedure)
结局指标
主要结局
Numeric rating scale (NRS), Oswestry Disability Index (ODI)
时间窗: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
duration of significant pain relief, opioid intake, and return to work
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