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

This study has been terminated.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00780390
First received: May 8, 2008
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Complex Regional Pain Syndrome
 Device: Spinal Cord Stimulator
Other: CRPS patients under treatment other than spinal cord stimulator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Muscle sympathetic nerve activity [ Time Frame: Before and after spinal cord stimulator implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate and blood pressure responses [ Time Frame: Before and after spinal cord stimulator ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
CRPS patients declining spinal cord stimulation therapy
 Other: CRPS patients under treatment other than spinal cord stimulator
RSD CRPS Not currently using a spinal cord stimulator
Other Name: Any brand
Active Comparator: 2
CRPS patients who are candidates for spinal cord stimulator implant
 Device: Spinal Cord Stimulator
SCS before and after implant
Other Name: Any brand

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780390

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

No publications provided

Responsible Party: Peter Konrad M.D PhD., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00780390     History of Changes
Other Study ID Numbers: 071060, CTSA 1 UL 1 RR024975 NCRR/NIH
Study First Received: May 8, 2008
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Mental Disorders
Autonomic Nervous System Diseases
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 22, 2013