Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in muscle sympathetic nerve activity
研究概览
简要总结
To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one that give us the fight and flight response). Therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from CRPS patients to different stimuli will differ significantly pre and post SCS implant.
If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their sympathetic function pre-implant. It is expected that patients with a moderate/mild form of autonomic dysfunction will have better outcomes with the SCS.
详细描述
Currently the mechanisms of Complex Regional Pain Syndrome (CRPS) are poorly understood and stratification of either diagnosis or therapy is very weak. . There is a great need to develop and validate more objective methods to characterize and stratify CRPS that better diagnostic and therapeutic approaches are available. Spinal Cord Stimulation (SCS) has been used as the last resource to alleviate pain and re-establish function in CRPS patients. However, there is a disagreement over how it works. An underlying concept is that it works by modulating autonomic nervous system (ANS) activity. Therefore, ANS parameters could be useful to stratify patients. Our preliminary studies indicated that SCS has also an effect on blood pressure regulation and improves the CRPS patients' response to Valsalva maneuver -a test of autonomic function. The Autonomic Nervous System function in adult CRPS patients has not yet been studied. The only existing study of CRPS and autonomic function showed that 15% of the patients suffer from syncope and increased heart rate during upright position similar to same aged patients with postural tachycardia syndrome - a syndrome of autonomic dysfunction. It is unclear if autonomic dysfunction is present in CRPS patients because ANS activity is altered by chronic pain or whether or not ANS activity contributes to CRPS. Therefore, we proposed to study the autonomic function in CRPS patients by standardized autonomic function and to evaluate the effect of the SCS on autonomic function in CRPS patients before and after spinal cord stimulator implant. This is a 24 months study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRPS patients meeting the inclusion criteria according to the International Association for the Study of pain task Force will be included in the study.
- •Age: 18 to
- •Disease duration of at least 6 months.
- •History of unsuccessful long lasting therapies: physical therapy, transcutaneous electrical stimulation and medication.
排除标准
- •Presence of current or past pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to CRPS.
- •Anticoagulant therapy, cardiac pacemaker used.
- •Pregnancy test for females is positive.
研究组 & 干预措施
CRPS patients: candidates for spinal cord stimulator
CRPS patients who are candidates for spinal cord stimulator implant. These patients will have Autonomic Function assessments before and after the Standard of Care spinal cord stimulation implant
干预措施: Autonomic Function Assessment (Other)
CRPS patients without spinal cord stimulation
CRPS patients declining spinal cord stimulation therapy. Autonomic Function will be assessed at baseline and again within 2 years.
干预措施: Autonomic Function Assessment (Other)
结局指标
主要结局
Change in muscle sympathetic nerve activity
时间窗: At baseline and within 2 years
Electrical neurography data from sympathetic nerves
次要结局
- Heart rate and blood pressure responses(At baseline and within 2 years)
- Heart rate(At baseline and within 2 years)
- Blood pressure response(At baseline and within 2 years)
研究者
Peter Konrad
Professor of Neurological Surgery
Vanderbilt University Medical Center