Restore Claims Characterization Study

This study has been completed.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200122
First received: September 12, 2005
Last updated: January 20, 2009
Last verified: October 2007
  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
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 ClinicalTrials.gov identifier: NCT00200122

Locations
United States, Illinois
Contact Medtronic for Exact Location
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
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 August 26, 2014