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Spinal Cord Stimulation for Low Back Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Precision Spinal Cord Stimulation System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Back Pain, Low Back Pain, Chronic Pain, Spinal Cord Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics; Age ≥18 years; Have pain of neuropathic origin; Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures. Exclusion Criteria: 1. Enrollment in any research that would conflict with study requirements.

Sites / Locations

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Outcomes

Primary Outcome Measures

Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"

Secondary Outcome Measures

Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation

Full Information

First Posted
September 13, 2005
Last Updated
May 23, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00205868
Brief Title
Spinal Cord Stimulation for Low Back Pain
Official Title
Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 2004 (Actual)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain. Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Back Pain, Low Back Pain, Chronic Pain, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Precision Spinal Cord Stimulation System
Intervention Description
Stimulation on throughout study
Primary Outcome Measure Information:
Title
Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Description
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Time Frame
1 year
Title
Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Description
Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics; Age ≥18 years; Have pain of neuropathic origin; Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures. Exclusion Criteria: 1. Enrollment in any research that would conflict with study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramsin Benyamin, MD
Organizational Affiliation
Millenium Pain Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Center
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
Research Center
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Center
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Research Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Research Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33477
Country
United States
Facility Name
Research Center
City
Lewiston
State/Province
Idaho
ZIP/Postal Code
83501
Country
United States
Facility Name
Research Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Center
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60707
Country
United States
Facility Name
Research Center
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Research Center
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Center
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Research Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55904
Country
United States
Facility Name
Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Center
City
Hamilton
State/Province
Ohio
ZIP/Postal Code
45011
Country
United States
Facility Name
Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Research Center
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29302
Country
United States
Facility Name
Research Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Center
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Research Center
City
Cudahy
State/Province
Wisconsin
ZIP/Postal Code
53220
Country
United States
Facility Name
Research Center
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States

12. IPD Sharing Statement

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Spinal Cord Stimulation for Low Back Pain

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