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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00780390

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndrome	Other: Autonomic Function Assessment	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in muscle sympathetic nerve activity [At baseline and within 2 years]

Secondary Outcome Measures

Heart rate and blood pressure responses [At baseline and within 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.