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Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity

NCT ID: NCT00399841

Last Updated: 2020-12-19

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

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-11-30

Brief Summary

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The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.

Detailed Description

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The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a "well placed single lead will generally perform better than a dual lead." Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites.

This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.

Conditions

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Intractable Neuropathic Pain Pain Back Pain Lower Extremity Pain

Keywords

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Pain Chronic Pain Neurostimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Stimulation will occur at the T7 followed by T8 during the trial implant period

Group Type ACTIVE_COMPARATOR

Precision for Spinal Cord Stimulation

Intervention Type DEVICE

During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.

2

Stimulation will occur at the T8 followed by T7 during the trial implant period

Group Type ACTIVE_COMPARATOR

Precision for Spinal Cord Stimulation

Intervention Type DEVICE

During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.

Interventions

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Precision for Spinal Cord Stimulation

During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for SCS, and have independently elected SCS as next line of therapy.
* 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 sensory loss in the low back or lower extremity as the primary complaint.
* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
* Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
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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Roshini Jain

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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Anesthesia Associates of Belleville

Belleville, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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SCS0306

Identifier Type: -

Identifier Source: org_study_id