Restore Claims Characterization Study
This study has been completed.
Sponsor:
MedtronicNeuro
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200122
First received: September 12, 2005
Last updated: January 20, 2009
Last verified: October 2007
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Purpose
The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome |
Device: Spinal Cord Stimulation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | Restore Claims Characterization Study |
Resource links provided by NLM:
Further study details as provided by MedtronicNeuro:
Primary Outcome Measures:
- The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
Secondary Outcome Measures:
- Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2005 |
| Study Completion Date: | August 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200122
Locations
| United States, Illinois | |
| Contact Medtronic for Exact Location | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Contact Medtronic for Exact Location | |
| Indianapolis, Indiana, United States | |
| United States, Missouri | |
| Contact Medtronic for Exact Location | |
| Kansas City, Missouri, United States | |
| United States, New York | |
| Contact Medtronic for Exact Location | |
| Syosset, New York, United States | |
| United States, Oregon | |
| Contact Medtronic for Exact Location | |
| Eugene, Oregon, United States | |
| United States, Texas | |
| Contact Medtronic for Exact Location | |
| Dallas, Texas, United States | |
| Contact Medtronic for Exact Location | |
| San Antonio, Texas, United States | |
| United States, West Virginia | |
| Contact Medtronic for Exact Location | |
| Huntington, West Virginia, United States | |
Sponsors and Collaborators
MedtronicNeuro
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00200122 History of Changes |
| Other Study ID Numbers: | 1617 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Causalgia Fibrosis Pain, Intractable Complex Regional Pain Syndromes Failed Back Surgery Syndrome Autonomic Nervous System Diseases Nervous System Diseases Peripheral Nervous System Diseases |
Neuromuscular Diseases Neuralgia Pathologic Processes Pain Neurologic Manifestations Signs and Symptoms Back Pain Postoperative Complications |
ClinicalTrials.gov processed this record on May 16, 2013