Restore Claims Characterization Study

Completed · Phase 4

Conditions studied: Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

In brief

The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.

Key facts

Study ID

NCT00200122

Run by

MedtronicNeuro

People needed

100

Starts

2005-01-01

Expected to finish

2007-08-01

Last updated by the study team

2009-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Requires, or will in the future, diathermy treatments.
• Had implanted spinal cord stimulation system within the last six months.

Where it is running

• Contact Medtronic for Exact Location — Chicago, Illinois, United States
• Contact Medtronic for Exact Location — Indianapolis, Indiana, United States
• Contact Medtronic for Exact Location — Kansas City, Missouri, United States
• Contact Medtronic for Exact Location — Syosset, New York, United States
• Contact Medtronic for Exact Location — Eugene, Oregon, United States
• Contact Medtronic for Exact Location — Dallas, Texas, United States
• Contact Medtronic for Exact Location — San Antonio, Texas, United States
• Contact Medtronic for Exact Location — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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