Effect of Pulse Width With Spinal Cord Stimulation
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation|
- Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) [ Time Frame: Within 6 months post-implantation ] [ Designated as safety issue: No ]Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"
|Study Start Date:||November 2006|
|Study Completion Date:||November 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.
Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399516
|United States, Alabama|
|Comprehensive Pain Management and Rehabilitation|
|Daphne, Alabama, United States, 36526|
|Principal Investigator:||Thomas Yearwood, MD||Comprehensive Pain and Rehabilitation|