Status:
COMPLETED
Spinal Cord Stimulation Research Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Chronic Low Back and Leg Pain
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00737581
Start Date
August 1 2008
End Date
April 1 2009
Last Update
February 1 2017
Active Locations (2)
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1
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, United States, 55435
2
Center for Pain Control
Garland, Texas, United States, 75042