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Spinal Cord Stimulation Research Study

This study has been completed.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00737581
First received: August 15, 2008
Last updated: April 27, 2009
Last verified: April 2009
History of Changes
  Purpose

The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.


Condition
Chronic Low Back and Leg Pain.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Posture Responsive Spinal Cord Stimulation Research Study

Further study details as provided by MedtronicNeuro:

Estimated Enrollment: 30
Study Start Date: August 2008
Study Completion Date: April 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients implanted with a spinal cord stimulator.

Criteria

Inclusion Criteria:

  • Be ambulatory
  • Be 18 years of age or older
  • Have chronic low back pain and/or leg pain due to neuropathic causes
  • Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
  • Be implanted with percutaneous thoracic leads
  • Have stable pain control
  • Adjust stimulation parameters manually on a regular basis
  • Be willing and able to complete protocol requirements
  • Be willing and able to provide written informed consent
  • Be male or nonpregnant female

Exclusion Criteria:

  • Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
  • Be morbidly obese
  • Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737581

Locations
United States, Minnesota
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, United States, 55435
United States, Texas
Center for Pain Control
Garland, Texas, United States, 75042
Sponsors and Collaborators
MedtronicNeuro
Investigators
Principal Investigator: David M Schultz, MD Medical Advanced Pain Specialists
Principal Investigator: Cristy Schade, MD Center for Pain Control
  More Information

No publications provided

Responsible Party: Medtronic Neuromodulation, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00737581     History of Changes
Other Study ID Numbers: 1648
Study First Received: August 15, 2008
Last Updated: April 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
Subject's
response
changes
in spinal
 cord
stimulation
during
postural

ClinicalTrials.gov processed this record on May 16, 2013