Evaluation of the Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients: A Prospective, Randomized, Double-Blind, Equivalence, Controlled Trial of Percutaneous Lumbar Adhesiolysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 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
To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
To 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 lower extremity pain secondary to post lumbar laminectomy syndrome, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.
This is a single-center, prospective, randomized, double-blind, equivalence, controlled trial performed in an interventional pain management referral center in the United States.
The study involves 240 patients studied in 4 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
- •Inclusion criteria:
- •History of lumbar surgery of at least 6 months duration in the past
- •Patients over the age of 18 years
- •Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration (post-surgery)
- •Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements.
排除标准
- •Facet joints, uncontrollable as sole pain generators
- •Unstable or heavy opioid use (400 mg of morphine equivalents daily)
- •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 anesthetic, steroids, or hypertonic sodium chloride solution.
研究组 & 干预措施
Double substitutes
Group IV will receive adhesiolysis, local anesthetic, and 0.9% sodium chloride solution to substitute for the 10% hypertonic sodium chloride, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
干预措施: Adhesiolysis (Procedure)
Celestone
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
干预措施: Adhesiolysis (Procedure)
sodium chloride solution
Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
干预措施: Adhesiolysis (Procedure)
sodium choride solution
Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;
干预措施: 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