TerminatedNot Applicable

Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome

Stopped: Lack of enrollment and discontinued funding

United States10 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in muscle sympathetic nerve activity

Timeframe: At baseline and within 2 years

Trial details

NCT IDNCT00780390

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

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