Autonomic Function Testing and Spinal Cord Stimulation in Chronic Visceral Pain (AFTSCSCVP)

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00678717
First received: May 8, 2008
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to assess the effect of the spinal cord stimulator (A small wire is surgically implanted under the skin. Low-level electrical signals are then transmitted through the lead to the spinal cord to alleviate pain. Using a magnetic remote control, the patients can turn the current on and off, or adjust the intensity.) on the autonomic nervous system (sympathetic and parasympathetic). Some studies support that the spinal cord stimulation suppresses or decreases sympathetic outflow (the sympathetic nervous system is the one that provide us with the "flight and fight response" and the parasympathetic nervous system is the one that works while we "sleep, rest and digest".). The sympathetic nervous system is important in blood pressure regulation also. However, there are not reports regarding the effect of the spinal cord stimulation on blood pressure regulation in chronic visceral pain patients. Most clinical trials are focus on the effect of the spinal cord stimulation on pain relief. We think we could use blood pressure, heart rate and special analysis of these signals and their relationship to other pain measurements to assess the effect of the spinal cord stimulation in an objective way.


Condition Intervention Phase
Chronic Pain
Device: "Sham"
Device: Medtronic or ANS spinal cord stimulator
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Autonomic Function Testing and Spinal Cord Stimulation: Implications for Successful Therapy in Chronic Visceral Pain

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • MSNA [ Time Frame: Before and after spinal cord stimulator implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate and blood pressure [ Time Frame: Before and after spinal cord stimulator ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Healthy
Healthy volunteers
Device: "Sham"
Physiological stimuli
Active Comparator: Chronic Visceral Pain
Patients
Device: Medtronic or ANS spinal cord stimulator
Spinal cord stimulator implant

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronic visceral pain patients candidates for spinal cord stimulation implant with no other chronic diseases.

Exclusion Criteria:

  • Diabetes, pulmonary or chronic cardiac diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678717

Locations
United States, Tennessee
Interventional Pain Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sukdeb Datta, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Sukdeb Datta M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00678717     History of Changes
Other Study ID Numbers: 071179, CTSA1 UL 1RR024975 NCRR/NIH
Study First Received: May 8, 2008
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
abdominal
Pelvic
Pain
SCS
Healthy and Chronic Visceral Pain patients
Chronic Visceral Pain and spinal cord stimulator

Additional relevant MeSH terms:
Chronic Pain
Visceral Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nociceptive Pain

ClinicalTrials.gov processed this record on August 21, 2014