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An Implantable Spinal Cord Stimulation Pain Management System

NCT ID: NCT00205855

Last Updated: 2012-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-03-31

Brief Summary

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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 Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.

Detailed Description

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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.

Conditions

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

Keywords

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Pain Chronic Pain Neurostimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Precision SCS

Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system

Group Type EXPERIMENTAL

Precision SCS

Intervention Type DEVICE

Advanced Bionics totally implantable Spinal 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: failed back surgery syndrome, intractable low back pain and leg pain.

Interventions

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Precision SCS

Advanced Bionics totally implantable Spinal 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: failed back surgery syndrome, intractable low back pain and leg pain.

Intervention Type DEVICE

Other Intervention Names

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Stimulus System PRECISION Spinal Cord Stimulator System (PRECISION System)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kay Adair

Role: STUDY_CHAIR

Boston Scientific Corporation

Locations

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Alabama Pain Center

Huntsville, Alabama, United States

Site Status

California Pain Medicine Centers

Los Angeles, California, United States

Site Status

Pacific Pain Treatment Center

San Francisco, California, United States

Site Status

Yellowstone Neurological Associates

Billings, Montana, United States

Site Status

Northshore University Hospital

Syosset, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Dallas Neurological Associates

Dallas, Texas, United States

Site Status

River Oaks Pain Management

Houston, Texas, United States

Site Status

Texas Back Institute

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CR-S-003

Identifier Type: -

Identifier Source: org_study_id