Orthotrac Pneumatic Vest: A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- VAS
研究概览
简要总结
Hypothesis - This study is designed to evaluate the results of using the Orthotrac Pneumatic Vest versus an EZ form brace in patients with radiating leg pain from disc bulge / protrusion / herniation. Specifically, our hypothesis is that patients given the Orthotrac Pneumatic Vest (OPV) will have greater pain relief and increased self-reported functionality and fewer progressions to surgery than those using the EZ form brace.
详细描述
Patient Inclusion / Exclusion Criteria:
Patient's who present with low back and unilateral leg pain are potential candidates for recruitment in this study. For purposes of the research, leg pain will constitute symptoms extending down the leg beyond the knee. The contralateral side may have pain in the buttock and down the posterior thigh but not below the knee. The criteria are as follows:
Inclusion / Exclusion:
- Age 21 - 55
- Preferred no prior surgery or no spine surgery in previous 6 months.
- No neurological deficit
- VAS > 4.0
- Symptoms unresolved after 4 weeks
- Minimal antalgic lean of the trunk when initially weight bearing
- Pain aggravated by weight bearing standing / walking
- Reduced leg pain on recumbency
- MRI Confirmed disc bulge / protrusion / herniation (HNP) site consistent with symptoms - preferred.
Patient Recruitment:
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
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 - 55
- •Preferred no prior surgery or no spine surgery in previous 6 months.
- •VAS > 4.0
- •Symptoms unresolved after 4 weeks
- •Minimal antalgic lean of the trunk when initially weight bearing
- •Pain aggravated by weight bearing standing / walking
- •Reduced leg pain on recumbency
- •MRI Confirmed disc bulge / protrusion / herniation (HNP) site consistent with symptoms - preferred.
排除标准
- •· No neurological deficit
结局指标
主要结局
VAS
Oswestry
SF-36
次要结局
- ROM
- Pain drawing
- Medication use
- Wear compliance
- Extra-protocol treatment seeking