Restore Claims Characterization Study

This study has been completed.
Information provided by:
MedtronicNeuro Identifier:
First received: September 12, 2005
Last updated: January 20, 2009
Last verified: October 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00200122

United States, Illinois
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Chicago, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Missouri
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Kansas City, Missouri, United States
United States, New York
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Syosset, New York, United States
United States, Oregon
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Eugene, Oregon, United States
United States, Texas
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Dallas, Texas, United States
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San Antonio, Texas, United States
United States, West Virginia
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Huntington, West Virginia, United States
Sponsors and Collaborators
  More Information 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:
Complex Regional Pain Syndromes
Failed Back Surgery Syndrome
Pain, Intractable
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Back Pain
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Postoperative Complications
Signs and Symptoms processed this record on May 26, 2016