Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome

Complex Regional Pain Syndrome Clinical Trial

— CRPS  

Official title:

Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00780390
• Other study ID #: 071060
• Secondary ID: CTSA 1 UL 1 RR02
• Status: Terminated
• Phase: N/A
• First received: May 8, 2008
• Last updated: February 26, 2018
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Primary Dysautonomias
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Autonomic Function Assessment

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle sympathetic nerve activity		At baseline and within 2 years
Secondary	Heart rate and blood pressure responses		At baseline and within 2 years