Effect of Pulse Width With Spinal Cord Stimulation

Pain Clinical Trial

Official title:

The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399516
• Other study ID #: SCS0706
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2006
• Last updated: March 7, 2012
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Pain

Intervention

Device:
• Precision

Locations

Country	Name	City	State
United States	Comprehensive Pain Management and Rehabilitation	Daphne	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)	Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"	Within 6 months post-implantation	No