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Spinal Cord Stimulation Research Study

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ClinicalTrials.gov Identifier: NCT00737581
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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

Condition or disease
Chronic Low Back and Leg Pain

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Posture Responsive Spinal Cord Stimulation Research Study
Study Start Date : August 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00737581     History of Changes
Other Study ID Numbers: 1648
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

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