Efficacy Of Interlaminar Epidural Injection With or Without Steroid For Low Back Pain Due To Lumbar Canal Stenosis: A Randomised Double Blind Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate and compare the efficacy of lumbar interlaminar epidural injection (ILEI) with following parameters in both the groups:
研究概览
简要总结
Spinal canal stenosis is the narrowing of the spinal canal which results in spinal cord and spinal nerve compression. It can cause back and leg pain, limb weakness, and numbness. Patients with symptomatic spinal canal stenosis have reduced activity which further leads to development of other serious complications.
The cause of the disease is generally degenerative. Acquired spinal canal stenosis is very common among elderly patients, with a prevalence of 1.7% - 13.1%.Primary treatment is conservative management, but in many cases when conservative therapy is not effective then surgical treatment is selected. But even after surgery symptoms may persist and long term benefits of surgery is reported to be less compared to conservative management. The risk of anesthesia and postoperative complication is also increased in elderly patients.
An epidural steroid injection is a non-operative minimally invasive procedure used for pain relief in spinal canal stenosis. The main aim is providing effective and long lasting pain relief with improvement in functional status for the management of chronic back pain and lower extremity pain. Various studies have been conducted to evaluate the efficacy of this treatment in the management of patients with spinal canal stenosis with highly variable success rate, still there is no consensus on its effect size nor on the timing of the trial, frequency, and duration of treatment. So further studies are required to understand the effectiveness of epidural steroid injection in the treatment of spinal canal stenosis.
Therefore this study is planned to evaluate the efficacy of interlaminar epidural steroid injection for back pain due lumbar canal stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having chronic lower back pain due lumbar canal stenosis as evident from radiological findings on MRI.
排除标准
- •Patients with- 1) Contraindication to the procedure (active, local or systemic infections), coagulopathy, use of anti thrombotic or anti platelet medications.
- •History of allergy to contrast medium or injected medication.
- •Previous history of low back surgery.
- •Lower Back Pain due to PIVD.
- •Pre-existing uncontrolled hypertension, uncontrolled diabetes mellitus type 2.
结局指标
主要结局
To evaluate and compare the efficacy of lumbar interlaminar epidural injection (ILEI) with following parameters in both the groups:
时间窗: a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months. | b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months.
时间窗: a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months. | b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
时间窗: a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months. | b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
次要结局
- To compare the following parameters in both groups:(a) Requirement of repeat ILEI.)
研究者
PAWAN KUMAR DUBEY
GEETANJALI MEDICAL COLLEGE AND HOSPITAL
