Correlation between vitamin D level and outcomes of transforaminal epidural steroid injection in lumbar radiculopathy: A Prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- NUMERICAL RATING SCALE ,
研究概览
简要总结
Aims and Objectives:
•**Primary Objective:**To compare the analgesic effect of Transforaminal Epidural Steroid Injection in patients with and without Vitamin D deficiency.
•**Secondary Objective:**To compare the change in Oswestry Disability Index (ODI) between pre and post procedure in the control and study groups
•Study Design**:**A prospective observational study
•Study Site: SGPGIMS
•Study Duration : 2 year
•Study Population : 80 patients
***Outcome Measures:***•Severity of pain would be assessed by Numeric Rating Scale (**NRS)**at baseline, 2hr after intervention, 2 weeks, 1st month and 3rd month postoperatively either in follow up OPD or telephonically. Success of intervention would be defined as more than 50 % reduction in NRS from baseline values.
•Oswestry Disability Index (ODI) would be calculated at baseline, 2 weeks, 1st month and 3rd month**.**
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing transforaminal epidural steroidal injection for radicular low back pain with single level lumbar disc herniation and no co-existing or pre-existing spine pathology.
排除标准
- •Patients with negative consent, significant bleeding diathesis, systemic or local infections, sever degenerative changes, surgical posterior fusion, daily supplementation of vitamin D, history of renal stones or trauma.
结局指标
主要结局
NUMERICAL RATING SCALE ,
时间窗: AT BASELINE, 2 WEEKS POST PROCEDURE, 4 WEEKS POST PROCEDURE, 3 MONTHS POST PROCEDURE
次要结局
- OSWESTRY DISABILITY INDEX FOR BACK PAIN(AT BASELINE, 2 WEEKS POST PROCEDURE, 4 WEEKS POST PROCEDURE, 3 MONTHS POST PROCEDURE)
研究者
Sanjay Kumar
Sanjay Gandhi Post Graduate Institute of Medical Sciences