Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-02-28

Brief Summary

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This study will systematically evaluate the programming parameters of the Precision Spinal Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side effects.

Detailed Description

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This study will investigate the efficacy of subthreshold intraspinal nerve root stimulation (INRS) in treating back pain. The efficacy of this strategy will be tested against dorsal column stimulation (DCS), the commonly-accepted technique for spinal cord stimulation. DCS will be tested at subthreshold and suprathreshold (perceptible) amplitudes. A substudy will involve patients who prefer suprathreshold DCS over INRS and subthreshold DCS. Its purpose is to systematically assess the pain relief afforded by a number of programs with different pulse widths. The overall purpose of this study is to investigate methods of making pain relief via electrical stimulation more comfortable by either using subthreshold amplitudes or by adjusting the pulse width of perceptible stimulation to a more pleasing range.

Conditions

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Back Pain

Keywords

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Failed Back Surgery Syndrome Back Pain Chronic Pain Spinal Cord Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Precision Spinal Cord Stimulation System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome.
* Be an appropriate candidate for Spinal Cord Stimulation (SCS) and for the surgical procedures required for SCS.
* Have experienced significant though short-lived pain relief with local anesthetic injection.
* Be 18 years of age or older.
* Be willing and able to comply with all study related procedures and visits.
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria

* Have any significant medical condition that is likely to interfere with study procedures.
* Have any evidence of neurologic instability.
* Have any other chronic pain condition.
* Have a condition currently requiring or likely to require the use of MRI or diathermy.
* Have an active implantable device.
* Are pregnant or planning to become pregnant in the next year.
* Are a current substance abuser (including alcohol and illicit drugs).
* Have a significant psychiatric disorder.
* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other trial during the duration of this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Boston Scientific Corporation

Principal Investigators

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Thomas Yearwood, MD

Role: PRINCIPAL_INVESTIGATOR

Comprehensive Pain and Rehabilitation

Locations

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Comprehensive Pain & Rehabilitation

Daphne, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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SCS0705

Identifier Type: -

Identifier Source: org_study_id