Spinal Cord Stimulation for Low Back Pain

Chronic Pain Clinical Trial

Official title:

Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205868
• Other study ID #: PM -SCS -120904
• Status: Completed
• Phase: Phase 4
• Start date: December 2004
• Est. completion date: December 2007

Study information

• Verified date: May 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;

2. Age =18 years;

3. Have pain of neuropathic origin;

4. 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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Device:
• Precision Spinal Cord Stimulation System
Stimulation on throughout study

Locations

Country	Name	City	State
United States	Research Center	Allentown	Pennsylvania
United States	Research Center	Billings	Montana
United States	Research Center	Bloomington	Illinois
United States	Research Center	Boston	Massachusetts
United States	Research Center	Chicago	Illinois
United States	Research Center	Cudahy	Wisconsin
United States	Research Center	Cullman	Alabama
United States	Research Center	Daphne	Alabama
United States	Research Center	Eugene	Oregon
United States	Research Center	Hamilton	Ohio
United States	Research Center	Huntsville	Alabama
United States	Research Center	Jacksonville	Florida
United States	Research Center	Jupiter	Florida
United States	Research Center	Lewiston	Idaho
United States	Research Center	Los Angeles	California
United States	Research Center	Merrillville	Indiana
United States	Research Center	Mesa	Arizona
United States	Research Center	Murray	Utah
United States	Research Center	Oak Brook	Illinois
United States	Research Center	Pasadena	California
United States	Research Center	Philadelphia	Pennsylvania
United States	Research Center	Pittsfield	Massachusetts
United States	Research Center	Provo	Utah
United States	Research Center	Rice Lake	Wisconsin
United States	Research Center	Rochester	Minnesota
United States	Research Center	San Diego	California
United States	Research Center	Spartanburg	South Carolina
United States	Research Center	Valparaiso	Indiana
United States	Research Center	Westminster	Colorado
United States	Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	1 year
Primary	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"	1 year
Secondary	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		1 year