Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome

NCT00780390 | Terminated

• 2 other identifiers: 071060CTSA 1 UL 1 RR024975 NCRR/NIH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome

Keywords

RSD; SCS; CRPS; Complex regional pain syndrome patients before undergoing spinal cord stimulator implant and under other treatments

Outcome Measures

Primary Outcomes (1)

• Change in muscle sympathetic nerve activity

  At baseline and within 2 years

Secondary Outcomes (1)

• Heart rate and blood pressure responses

  At baseline and within 2 years

Study Arms (2)

CRPS patients without spinal cord stimulation

PLACEBO COMPARATOR

CRPS patients declining spinal cord stimulation therapy. Autonomic Function will be assessed at baseline and again within 2 years.

Other: Autonomic Function Assessment

CRPS patients: candidates for spinal cord stimulator

EXPERIMENTAL

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

Interventions

Autonomic Function Assessment OTHER

CRPS patients without spinal cord stimulation; CRPS patients: candidates for spinal cord stimulator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65.
• Disease duration of at least 6 months.
• History of unsuccessful long lasting therapies: physical therapy, transcutaneous electrical stimulation and medication.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Peter Konrad, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: October 27, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)