Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Low Back Pain
- 发起方
- Verium Diagnostics, Inc.
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Change from Baseline in Pain Visual Analog Scale
- 状态
- 终止
- 最后更新
- 14年前
概览
简要总结
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
详细描述
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from Baseline in Pain Visual Analog Scale
时间窗: Upon enrollment (day 1 - baseline) and four weeks and eight weeks
The subjects will complete a form indicating their pain level upon enrollment. Subjects will then be scanned again at four weeks and at eight weeks. At the time of the scan subjects will also be asked to complete a follow up VAS. Upon completion of the study the change in VAS scores will be analyzed.
次要结局
- Change from Baseline Oswestry Disability Index (ODI)(Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks)