Restore Claims Characterization Study

NCT ID: NCT00200122

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-08-31

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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Spinal Cord Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedtronicNeuro

INDUSTRY

Sponsor Role lead

Locations

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Contact Medtronic for Exact Location

Chicago, Illinois, United States

Site Status

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Indianapolis, Indiana, United States

Site Status

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Kansas City, Missouri, United States

Site Status

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Syosset, New York, United States

Site Status

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Eugene, Oregon, United States

Site Status

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Dallas, Texas, United States

Site Status

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San Antonio, Texas, United States

Site Status

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Huntington, West Virginia, United States

Site Status

Countries

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United States

References

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O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Reference Type DERIVED
PMID: 34854473 (View on PubMed)

Other Identifiers

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1617

Identifier Type: -

Identifier Source: org_study_id

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