Comparison of Intraspinal Nerve Root Stimulation With Dor... | NCT00370773

Studies
Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation

NCT00370773

Sponsor

Boston Scientific Corporation

Status

Terminated

Last Update Posted

Sep 5, 2008Estimated

Enrollment

4Actual

Phase

Phase 4

Conditions

Back Pain

Interventions

Precision Spinal Cord Stimulation System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow Enrolling

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Feb 2007Actual

First Submitted Date

Aug 30, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Sep 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2008

Last Update Posted Date

Sep 5, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Name	Type	Description	Arm Group Labels	Other Names
Precision Spinal Cord Stimulation System	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this study is to compare subthreshold intraspinal nerve root stimulation (INRS) with subthreshold and suprathreshold dorsal column stimulation (DCS).		1 year
The primary safety endpoint is incidence of adverse events.		Throughout Study

Secondary Outcomes

Measure	Description	Time Frame
The secondary objectives of this study are to assess the effect of different stimulation types on average pain and pain-related disability, and to assess the subjective comfort of paresthesia with different pulse widths.		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thomas Yearwood, MD	Comprehensive Pain and Rehabilitation	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Comprehensive Pain & Rehabilitation		Daphne	Alabama	36526	United States

Condition Browse Module

MeSH Terms

ID	Term
D001416	Back Pain
D055111	Failed Back Surgery Syndrome
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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