NCT00205868

Spinal Cord Stimulation for Low Back Pain

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Precision Spinal Cord Stimulation System	Stimulation on throughout study

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2005-09-21
• Last updated: 2021-06-18
• Results posted: 2021-06-18

Locations

30 sites across 1 country: United States