Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
研究概览
简要总结
This study was aimed to investigate the impact of using different epidural volumes.
Patients with acute discogenic pain were included in the study.
详细描述
Objectives: This study was aimed to investigate the impact of using different epidural volumes.
Methods: Seventy five patients with acute discogenic pain were included in the study.The patients were randomly assigned to three groups. All patients received a single epidural dose of triamcinolone [80 mg] and 12.5 mg bupivacaine combination. The patients in Group 1, Group 2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections, respectively. The efficacy of treatment was assessed with VAS (visual analog scale) [O= no pain, 10 = unbearable pain], SLET(straight leg elevation test) [0° = worst, 85° = best], and Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients] before and 2 weeks after the EPSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acute discogenic pain with less than three months duration not responding to other modalities of conservative management [NSAIDs, physiotherapy, bracing, etc.],
- •radiological disc bulging accompanying unilateral root impingement symptoms,
- •an Oswestry daily activity score more than 20 percent, and
- •resistance to treatment.
排除标准
- •Patients with bilateral root impingement symptoms, neurological deficits, and/or history of previous lumbar disc surgery, severe cardiac, pulmonary, gastrointestinal, renal diseases, glaucoma, urinary retention, and/or known allergy to the drugs used in the study were excluded from the study.
研究组 & 干预措施
Epidural Volume 10mL
Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Triamcinolone (Drug)
Epidural Volume 10mL
Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Epidural Volume (Drug)
Epidural Volume 10mL
Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Bupivacaine (Drug)
Epidural Volume 15mL
Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Triamcinolone (Drug)
Epidural Volume 15mL
Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Epidural Volume (Drug)
Epidural Volume 15mL
Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Bupivacaine (Drug)
Epidural Volume 20mL
Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Triamcinolone (Drug)
Epidural Volume 20mL
Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Epidural Volume (Drug)
Epidural Volume 20mL
Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
干预措施: Bupivacaine (Drug)
结局指标
主要结局
VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
时间窗: 2 weeks
Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]
时间窗: 2 weeks
SLET(straight leg elevation test) [0° = worst, 85° = best]
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Neslihan Uztüre
assistant proffessor
Yeditepe University Hospital