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Restore Claims Characterization Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200122
First Posted: September 20, 2005
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MedtronicNeuro
September 12, 2005
September 20, 2005
January 21, 2009
January 2005
Not Provided
The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
Same as current
Complete list of historical versions of study NCT00200122 on ClinicalTrials.gov Archive Site
Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.
Same as current
Not Provided
Not Provided
 
Restore Claims Characterization Study
Restore Claims Characterization Study
The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
Device: Spinal Cord Stimulation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00200122
1617
Not Provided
Not Provided
Not Provided
Not Provided
MedtronicNeuro
Not Provided
Not Provided
MedtronicNeuro
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP