Restore Claims Characterization Study
Phase 4
Completed
- Conditions
- Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
- Registration Number
- NCT00200122
- Lead Sponsor
- MedtronicNeuro
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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 Criteria
- Requires, or will in the future, diathermy treatments.
- Had implanted spinal cord stimulation system within the last six months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.
Trial Locations
- Locations (1)
Contact Medtronic for Exact Location
🇺🇸Huntington, West Virginia, United States