NCT00370773

Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation

Treatment of Chronic Low Back Pain With Spinal Cord Stimulation: Comparison of Subthreshold Intraspinal Nerve Root Stimulation With Subthreshold and Suprathreshold Dorsal Column Stimulation and a Secondary Study of the Effect of Pulse Width

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

Summary

This study will systematically evaluate the programming parameters of the Precision Spinal Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side effects.

Detailed description

This study will investigate the efficacy of subthreshold intraspinal nerve root stimulation (INRS) in treating back pain. The efficacy of this strategy will be tested against dorsal column stimulation (DCS), the commonly-accepted technique for spinal cord stimulation. DCS will be tested at subthreshold and suprathreshold (perceptible) amplitudes. A substudy will involve patients who prefer suprathreshold DCS over INRS and subthreshold DCS. Its purpose is to systematically assess the pain relief afforded by a number of programs with different pulse widths. The overall purpose of this study is to investigate methods of making pain relief via electrical stimulation more comfortable by either using subthreshold amplitudes or by adjusting the pulse width of perceptible stimulation to a more pleasing range.

Conditions

• Back Pain

Interventions

Type	Name	Description
DEVICE	Precision Spinal Cord Stimulation System

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-12-01
• Completion: 2007-02-01
• First posted: 2006-09-01
• Last updated: 2008-09-05

Locations

1 site across 1 country: United States