Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region
研究概览
简要总结
Spinal stenosis is a prevalent diagnosis, which is handled in a heterogeneous manner by clinicians. Moreover, when using steroidal epidural injections, successful treatment is currently defined as the satisfaction of the patient from the treatments, a subjective and non-quantifiable indicator.
In this experiment, the investigators aim to evaluate thermographic images as an objective method for assessing the efficacy of steroidal epidural injections, the most common invasive treatment for pain associated with spinal stenosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed a valid, IRB/EC-approved informed consent form
- •18 years of age or older when written informed consent is obtained
- •Diagnosis of spinal stenosis by MRI or CT imaging
排除标准
- •Sensitivity to local anesthetics
- •Skin infection at the site of needle insertion
- •Had evidence of a peripheral neuropathy
- •Had clinical signs of peripheral vascular disease
- •Patient is pregnant
- •Clinical diagnosis of blood clotting disorder
- •Tumor or infection at spine as demonstrate at MRI Unbalanced Cardiac Insufficiency, hypertension & Diabetes cataract Stomach Ulcer
研究组 & 干预措施
Subject after epidural injection
Subjects are patients from the clinic who have been diagnosed with Lumbar spinal stenosis and determined eligible for receiving steroidal epidural injection for pain management
干预措施: Therm-AppTM TH, thermographic camera (Device)
Subject after epidural injection
Subjects are patients from the clinic who have been diagnosed with Lumbar spinal stenosis and determined eligible for receiving steroidal epidural injection for pain management
干预措施: epidural injection (Drug)
结局指标
主要结局
Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region
时间窗: Baseline and 30 min
次要结局
- Change in Pain Intensity by a 0 - 10 numerical rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine".(Baseline, 1 month, 3 months)
研究者
michal roll
Chief Executive Officer
Tel-Aviv Sourasky Medical Center