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Clinical Trials/NCT00200122
NCT00200122CompletedPhase 4

Restore Claims Characterization Study

MedtronicNeuro8 sites in 1 country100 target enrollmentStarted: January 2005Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
100
Locations
8
Primary Endpoint
The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
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.

Outcomes

Primary Outcomes

The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

Secondary Outcomes

  • Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.

Investigators

Sponsor Class
Industry

Study Sites (8)

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