Spinal Cord Stimulation for Low Back Pain

Phase 4

Completed

• Conditions: Chronic Pain

• Registration Number: NCT00205868
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Results First Submitted: 2021-03-31
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-23
• Last Update Submitted: 2021-05-23
• Results First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.	1 year	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.	1 year	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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Center; 🇺🇸 Rice Lake, Wisconsin, United States