Infrared (FLIR) Imaging as a Monitor for Sympathetic Blocks in Complex Regional Pain Syndrome (CRPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Circulation Improvement
研究概览
简要总结
This research proposal aims to investigate the potential use of Infrared (FLIR) imaging to monitor the successful achievement of the sympathetic blockade in patients with complex regional pain syndrome (CRPS).
详细描述
Sympathetic blocks are clinically used to diagnose and treat sympathetically mediated pain. Despite the frequent use of these blocks, there remains a need for an objective method to determine the achievement of a sympathetic block in the clinical setting.
Current clinical practice assess the success of a sympathetic block by observation of clinical signs of sympathetic blockade. These signs include monitoring skin temperature, pulse amplitude, blood oxygen, or any combination of these methods. However, clinical signs of sympathetic blockade often demonstrate an unpredictable or delayed response and can make monitoring difficult.
Therefore, it is necessary to develop an objective monitoring method that is reliable, rapid response, and not affected by the other confounders. One potential method is the use of thermal camera imaging (FLIR).
Such a monitor could increase procedural accuracy and efficiency, thus improving patient care. To plan the prospective treatment options, objective confirmation of successful sympathetic block is essential to differentiate sympathetically mediated pain (SMP) versus sympathetically independent pain (SIP).
In this context, utilization of a monitor with a rapid response and easy clinical applicability, would serve as an objective endpoint for evaluating sympathetic blockade both clinically and for future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is between 18 and 85 years old
- •Providing CRPS diagnostic criteria by using Budapest Clinical criteria [16]
- •The patient has had pain and other symptoms for more than 3 months
- •Not responding to conventional medical treatments and multidisciplinary approach
- •High NRS detection in pain assessment despite appropriate treatment (NRS = and > 6/10).
- •Pain is a limitation in the patient's functional capacity despite appropriate treatment.
排除标准
- •Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT).
- •Systemic or local infection
- •Coagulation disorders
- •History of allergy to contrast material
- •Malignancy
- •Pregnancy
- •Uncontrollable medical and psychiatric condition
- •The patients diagnosed with dysautonomia, sympathetic dysfunction (such as Raynaud disease or Buerger disease), sweating disorders (such as acquired idiopathic generalized anhidrosis), and patients on vasoactive drugs, the mechanism of action is directly on the vascular tone.
结局指标
主要结局
Circulation Improvement
时间窗: 5 minutes post procedure
Improvement of circulation and perfusion in the affected limb by FLIR camera in CRPS patients at a 5-minutes time point after the completion of the block.
次要结局
- Comparison between FLIR and Standard Measuring(5 minutes post procedure)
- Numerical Pain Score Correlation(10 days post procedure)