Effect of Pulse Width With Spinal Cord Stimulation

Phase 4

Completed

• Conditions: Back Pain; Pain; Chronic Pain

• Registration Number: NCT00399516
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-15
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Results First Submitted: 2012-02-13
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Results First Posted: 2012-04-04
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
• Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
• Be 18 years of age or older.
• Be willing and able to comply with all study related procedures and visits.
• Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria

• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
• Have any other chronic pain condition likely to confound evaluation of study endpoints.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)	Within 6 months post-implantation	Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"

Trial Locations

Locations (1)

Comprehensive Pain Management and Rehabilitation; 🇺🇸 Daphne, Alabama, United States