Clinical trial NCT00205868: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: Back Pain
Low Back Pain
Chronic Pain
Spinal Cord Stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
timeFrame: 1 year
measure: Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Research Center
state: Alabama
city: Daphne
country: United States
facility: Research Center
state: Alabama
city: Huntsville
country: United States
facility: Research Center
state: Alabama
city: Mesa
country: United States
facility: Research Center
state: Arizona
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Pasadena
country: United States
facility: Research Center
state: California
city: San Diego
country: United States
facility: Research Center
state: California
city: Westminster
country: United States
facility: Research Center
state: Colorado
city: Jacksonville
country: United States
facility: Research Center
state: Florida
city: Jupiter
country: United States
facility: Research Center
state: Florida
city: Lewiston
country: United States
facility: Research Center
state: Idaho
city: Bloomington
country: United States
facility: Research Center
state: Illinois
city: Chicago
country: United States
facility: Research Center
state: Illinois
city: Oak Brook
country: United States
facility: Research Center
state: Illinois
city: Merrillville
country: United States
facility: Research Center
state: Indiana
city: Valparaiso
country: United States
facility: Research Center
state: Indiana
city: Boston
country: United States
facility: Research Center
state: Massachusetts
city: Pittsfield
country: United States
facility: Research Center
state: Massachusetts
city: Rochester
country: United States
facility: Research Center
state: Minnesota
city: Billings
country: United States
facility: Research Center
state: Montana
city: Winston-Salem
country: United States
facility: Research Center
state: North Carolina
city: Hamilton
country: United States
facility: Research Center
state: Ohio
city: Eugene
country: United States
facility: Research Center
state: Oregon
city: Allentown
country: United States
facility: Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Research Center
state: South Carolina
city: Murray
country: United States
facility: Research Center
state: Utah
city: Provo
country: United States
facility: Research Center
state: Utah
city: Cudahy
country: United States
facility: Research Center
state: Wisconsin
city: Rice Lake
country: United States
facility: Research Center
state: Wisconsin
Study officials:
affiliation: Millenium Pain Center
name: Ramsin Benyamin, MD
role: PRINCIPAL_INVESTIGATOR
References: