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Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome (CRPS)

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ClinicalTrials.gov Identifier: NCT00780390
Recruitment Status : Terminated (Lack of enrollment and discontinued funding)
First Posted : October 27, 2008
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center

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.


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Other: Autonomic Function Assessment Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome
Study Start Date : January 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010


Arm Intervention/treatment
Placebo Comparator: 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.
Other: Autonomic Function Assessment
Experimental: 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
Other: Autonomic Function Assessment



Primary Outcome Measures :
  1. Change in muscle sympathetic nerve activity [ Time Frame: At baseline and within 2 years ]

Secondary Outcome Measures :
  1. Heart rate and blood pressure responses [ Time Frame: At baseline and within 2 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 65.
  • Disease duration of at least 6 months.
  • History of unsuccessful long lasting therapies: physical therapy, transcutaneous electrical stimulation and medication.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780390


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Peter Konrad, M.D. Vanderbilt University

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00780390     History of Changes
Other Study ID Numbers: 071060
CTSA 1 UL 1 RR024975 NCRR/NIH
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vanderbilt University Medical Center:
RSD
SCS
CRPS
Complex regional pain syndrome patients before undergoing spinal cord stimulator implant and under other treatments

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Autonomic Nervous System Diseases
Primary Dysautonomias
Disease
Pathologic Processes
Mental Disorders
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases