Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome (CRPS)
Primary Purpose
Complex Regional Pain Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autonomic Function Assessment
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndrome focused on measuring RSD, SCS, CRPS, Complex regional pain syndrome patients before undergoing spinal cord stimulator implant and under other treatments
Eligibility 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.
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
CRPS patients without spinal cord stimulation
CRPS patients: candidates for spinal cord stimulator
Arm Description
CRPS patients declining spinal cord stimulation therapy. Autonomic Function will be assessed at baseline and again within 2 years.
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
Outcomes
Primary Outcome Measures
Change in muscle sympathetic nerve activity
Secondary Outcome Measures
Heart rate and blood pressure responses
Full Information
NCT ID
NCT00780390
First Posted
May 8, 2008
Last Updated
February 26, 2018
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00780390
Brief Title
Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome
Acronym
CRPS
Official Title
Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment and discontinued funding
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome
Keywords
RSD, SCS, CRPS, Complex regional pain syndrome patients before undergoing spinal cord stimulator implant and under other treatments
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRPS patients without spinal cord stimulation
Arm Type
Placebo Comparator
Arm Description
CRPS patients declining spinal cord stimulation therapy. Autonomic Function will be assessed at baseline and again within 2 years.
Arm Title
CRPS patients: candidates for spinal cord stimulator
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Autonomic Function Assessment
Primary Outcome Measure Information:
Title
Change in muscle sympathetic nerve activity
Time Frame
At baseline and within 2 years
Secondary Outcome Measure Information:
Title
Heart rate and blood pressure responses
Time Frame
At baseline and within 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Konrad, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome
We'll reach out to this number within 24 hrs