A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 主要终点
- 40% change in Oswestry Disability Index
研究概览
简要总结
The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.
详细描述
The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Moderate to complete disability (baseline ODI score of 21 to 80 percent)
排除标准
- •Pregnant patients
- •Patients considering pregnancy
- •Patients in any other investigational device or drug study
- •Patients unwilling to return for follow up
- •Patients unwilling to provide access to medical claims associated with pain management.
研究组 & 干预措施
Intervention (Aspen Horizon 627 LSO)
Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management
干预措施: Aspen Horizon 627 LSO (Device)
Medical Management
Normal medical management
结局指标
主要结局
40% change in Oswestry Disability Index
时间窗: 4 weeks
Oswestry Disability Index
次要结局
- Change in Opioid utilization(4 weeks, 8 weeks, 12 weeks)
- General Health Survey(12 weeks)
- Number of participants with treatment-related adverse events as assessed by questionnaire(4 weeks, 8 weeks, 12 weeks)