Microneurography and Spinal Cord Stimulation in Chronic Visceral Pain

NCT00678717 | Terminated

• 1 other identifier: 071179
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

abdominal; Pelvic; Pain; SCS; Healthy and Chronic Visceral Pain patients; Chronic Visceral Pain and spinal cord stimulator

Outcome Measures

Primary Outcomes (1)

• Muscle sympathetic nerve activity

  Microneurography directly assesses muscle sympathetic nerve activity (MSNA)

  Prior to stimulator implant and within 1 year of receiving stimulator implant

Secondary Outcomes (2)

• Heart rate

  Before and up to 1 year after spinal cord stimulator implant

• blood pressure

  Before and up to 1 year after spinal cord stimulator implant

Study Arms (2)

Healthy

ACTIVE COMPARATOR

Healthy volunteers

Procedure: Autonomic Evaluation

Chronic Visceral Pain

EXPERIMENTAL

Chronic Visceral Pain patients. Participants will be tested before and after implantation of a Spinal Cord Stimulator (implantation of the Spinal Cord Stimulator is done as usual care and is not a study procedure)

Procedure: Autonomic Evaluation

Interventions

Autonomic Evaluation PROCEDURE

Orthostatic vital signs will be determined by measuring heart rate (HR) and brachial blood pressure (BP) during a tilt table test. The degree of vagal mediated sinus arrhythmia will be assessed during controlled breathing (5 seconds inhalation and 5 seconds exhalation during 90 seconds), and the sinus arrhythmia parameters will be calculated as the difference and ratio of the longest to the shortest RR interval. The sympathetic response during breath hold will be measured. Responses of BP, HR, MSNA will be acquired during Valsalva maneuver. The valsalva ratio of heart rate will be calculated from the maximum of heart rate during or shortly after straining and the minimal depressed heart rate in the overshoot phase IV. Blood pressure and MSNA increase during isometric handgrip maintained at 30% of maximal voluntary contraction for five minutes will be determined. The blood pressure and MSNA response will be measured during cold pressor test with the hand in ice water for 1 minute.

Chronic Visceral Pain; Healthy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetes, pulmonary or chronic cardiac diseases.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Interventional Pain Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sukdeb Datta, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 15, 2008
• Study Start: February 1, 2008
• Primary Completion: January 23, 2009
• Study Completion: January 23, 2009
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)