NCT00399841

Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity

Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity: A Comparison of Electrode Placement at T7 and T8

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.

Detailed description

The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a "well placed single lead will generally perform better than a dual lead." Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites. This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.

Conditions

• Intractable Neuropathic Pain
• Pain
• Back Pain
• Lower Extremity Pain

Interventions

Type	Name	Description
DEVICE	Precision for Spinal Cord Stimulation	During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-05-01
• Completion: 2008-11-01
• First posted: 2006-11-15
• Last updated: 2020-12-19
• Results posted: 2020-12-19

Locations

1 site across 1 country: United States