Phase 4 N=304 Treatment

Spinal Cord Stimulation for Low Back Pain

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT00205868 ↗

Enrolled (actual)

304

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Precision Spinal Cord Stimulation System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.	—	—
PRIMARY Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.	—	—
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	—	—

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

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

Enrollment in any research that would conflict with study requirements.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00205868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.