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COMPLETEDPhase 3NCT00205855

An Implantable Spinal Cord Stimulation Pain Management System

There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Ther...

Lead sponsor: Boston Scientific Corporation•9 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Boston Scientific Corporation

This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial Cord Stimulation(SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Dailed back surgery syndrome, intractable low backpain and leg pain.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain.
•2. Be an appropriate candidate for surgery.
•3. Be capable of giving informed consent.
•4. Be capable and willing to follow all study related procedures.

Exclusion Criteria

•1. Have an inability to operate the system either by self or care-giver.
•2. Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.
•3. Have any implanted electrical devices, regardless of whether active or inactive.
•4. Have any active implantable device regardless of whether stimulation is ON or OFF.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 26, 2012Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment65

Start dateFeb 2003

Last updatedOct 26, 2012

Condition

Chronic Pain Pain, Intractable Pain Back Pain Failed Back Surgery Syndrome

Locations shown

Alabama Pain Center

Huntsville, Alabama

California Pain Medicine Centers

Los Angeles, California

Pacific Pain Treatment Center

San Francisco, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2012Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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