Clinical Trial: Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome
Brief Summary:
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.
Detailed Summary: 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.
Sponsor: Vanderbilt University
Current Primary Outcome: Muscle sympathetic nerve activity [ Time Frame: Before and after spinal cord stimulator implant ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Heart rate and blood pressure responses [ Time Frame: Before and after spinal cord stimulator ]
Original Secondary Outcome: Same as current
Information By: Vanderbilt University
Dates:
Date Received: May 8, 2008
Date Started: January 2008
Date Completion:
Last Updated: December 19, 2014
Last Verified: December 2014
