NCT02503787

OPTIONS Spinal Cord Stimulation Programming Parameters

A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Detailed description

Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study. The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Conditions

• Pain, Intractable

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulation (SCS)	SCS programming options

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-07-21
• Last updated: 2017-09-19
• Results posted: 2017-09-19

Locations

11 sites across 1 country: United States