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Clinical Trials/NCT00737581
NCT00737581
Completed
N/A

Posture Responsive Spinal Cord Stimulation Research Study

MedtronicNeuro2 sites in 1 country20 target enrollmentAugust 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Low Back and Leg Pain
Sponsor
MedtronicNeuro
Enrollment
20
Locations
2
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
April 2009
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (2)

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