Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Improvement in function (6 months post-injection)
研究概览
简要总结
Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. By assessing the relative efficacy of transforaminal epidural injections of particulate and nonparticulate steroids, this study attempts to further define the appropriate conservative management of painful unilateral radiculopathies due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months following the injection.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking/reading adults age 18-90 years
- •Patients with complaints of unilateral radicular lower extremity symptoms
- •NRS pain score >= 5
- •Pain symptoms for at least 1 month's duration
- •Patients deemed appropriate for lumbar transforaminal epidural steroid injections by treating spine specialist
- •Targeted injection level for L4 or L5
- •MRI of lumbosacral spine that demonstrates and confirms single-level neural compression secondary to unilateral lumbosacral foraminal or subarticular stenosis consistent with clinical history and findings
- •Lumbar foraminal stenosis severity of grades 1, 2, and 3
排除标准
- •Patients with multiple symptomatic levels
- •Patients who are deemed not appropriate to undergo lumbar transforaminal epidural steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast, patients with high bleeding tendency, pregnancy)
- •Patients involved with litigation or worker's compensation cases
- •Patients who are unable to answer the questionnaires and perform follow-up visits
- •Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis, greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or peripheral neuropathy) that may confuse clinical picture and impact patients' rating and perception of their low back and radicular symptoms
- •Patients with other spinal pathologies confirmed on imaging that may explain patient's pain
- •Patients who have additional severe foraminal stenosis inferior to the symptomatic level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will not have those levels injected
- •Non-English speakers
研究组 & 干预措施
Decadron
Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron.
干预措施: Decadron Phosphate, Injectable (Drug)
Decadron
Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron.
干预措施: Epidural Steroid Injection (Procedure)
Kenalog
Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog.
干预措施: Kenalog Injectable Product (Drug)
Kenalog
Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog.
干预措施: Epidural Steroid Injection (Procedure)
结局指标
主要结局
Improvement in function (6 months post-injection)
时间窗: 6 months post-injection
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Improvement in function (2 weeks post-injection)
时间窗: 2 weeks post-injection
This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Improvement in function (6 weeks post-injection)
时间窗: 6 weeks post-injection
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Improvement in function (3 months post-injection)
时间窗: 3 months post-injection
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
次要结局
- Medication use(2 weeks, 6 weeks, 3 months, and 6 months post-injection)
- Patient satisfaction with the procedure(2 weeks, 6 weeks, 3 months, and 6 months post-injection)
- Quality of life(2 weeks, 6 weeks, 3 months, and 6 months post-injection)
- Side effects(2 weeks, 6 weeks, 3 months, and 6 months post-injection)