The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
研究概览
简要总结
This study will be held on patients with failed back surgery syndrome, the investigators are comparing prolotherapy and steroids injections in caudal epidural space to relieve the pain
详细描述
This study is a prospective double blinded randomized controlled study. It will be held on patients with failed back surgery syndrome aged between 20 and 70 years old, one group will receive ultrasound and fluoroscopy-guided injection of prolotherapy in caudal epidural space while the other group will receive ultrasound and fluoroscopy-guided injection of steroids in the caudal epidural space 40 patients will be included in each group
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 (Care Provider, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) double blinded
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with failed back surgery syndrome, having chronic pain for more than 3 months by a detailed assessment including medical history and examination
- •patients having positive radiological (MRI) findings of spinal nerve roots being irritated or compressed after having surgery for one of many conditions including: lumbar disc herniation, spinal canal stenosis, osteophytes, spodylolithesis or foramen stenosis
- •patients whom another surgery is not indicated
排除标准
- •patient refusal
- •systemic infection or infection at the site of injection
- •patients on anticoagulation
- •immunocompromised patients as uncontrolled diabetes, osteoporosis as a contraindication for steroid injection
- •patients with renal impairment or on dialysis
- •acute disc prolapse as it requires immediate surgery
- •concurrent significant depressive illness, inflammatory of joint disease.
研究组 & 干预措施
Steroid group (Group S)
This group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection
干预措施: medthylprednisolone (Drug)
Prolotherapy group (Group P)
This group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection
干预措施: prolotherapy (Drug)
结局指标
主要结局
Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
时间窗: 2 weeks
A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful
次要结局
- further change in visual analogue scale(2 weeks till 6 months)
- recording the number of patients who encountered any complications and treating them accordingly(6 months)
- the level reached by the injectate(at time of injection)
- assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS) from 0 to 28 where 0 is so dissatisfied and 28 means very satisfied(6 months)
研究者
Ahmed Shehab, MD
Lecturer in Anaesthesia and Surgical ICU department
Alexandria University