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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
  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
Intervention Model: Parallel Assignment
Masking: Single
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00200122     History of Changes
Other Study ID Numbers: 1617
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: January 21, 2009
Last Verified: October 2007

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Failed Back Surgery Syndrome
Pain, Intractable
Causalgia
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Back Pain
Pain
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Neuralgia