Status:
COMPLETED
Restore Claims Characterization Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.
Eligibility Criteria
Inclusion
- Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD).
- Primary pain in the lower half of the body.
Exclusion
- Requires, or will in the future, diathermy treatments.
- Had implanted spinal cord stimulation system within the last six months.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00200122
Start Date
January 1 2005
End Date
August 1 2007
Last Update
January 21 2009
Active Locations (8)
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1
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Chicago, Illinois, United States
2
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Indianapolis, Indiana, United States
3
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Kansas City, Missouri, United States
4
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Syosset, New York, United States