NCT02116075Unknown2 期
Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.
Naveed Natanzi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain relief as measured by VAS pain scale.
研究概览
简要总结
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings.
- •Evidence of low back pain base upon one or more of the following:
- •i. Lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on VAS.
- •ii. Has received at lest 2 types of ancillary treatment (i.e. physical therapy, oral analgesia, acupuncture, etc.)
- •Men or women age greater than or equal to 18 years.
- •No significant alcohol use (7 or fewer drinks per week).
- •Patient has a history of at least 2 failed epidural CS injections.
排除标准
- •Treatment risk factors including one or more of the following:
- •i. Unstable or symptomatic cardiac complaints ii. Unstable or symptomatic respiratory complaints iii. Unable to reliably comprehend the protocol or reliably record data
- •Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
- •History of Malignancy
- •Any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease, polyneuropathy) or psychosocial condition that in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
研究组 & 干预措施
Epidural Steroid
Experimental
80mg depo-medrol 9mL 1% lidocaine
干预措施: Epidural Prolotherapy (Procedure)
Epidural Prolotherapy
Active Comparator
10ml of 5% generic dextrose
干预措施: Epidural Steroid (Procedure)
结局指标
主要结局
Pain relief as measured by VAS pain scale.
时间窗: 1 year
次要结局
- Disability score as determined by Oswstery questionnaire.(1 year)
- Change in the frequency and amount of opioid use.(1 year)
研究者
Naveed Natanzi
Resident Physician
VA Long Beach Healthcare System
研究点 (1)
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