Back to resultsEffect of Pulse Width With Spinal Cord Stimulation
Primary Purpose
Pain, Chronic Pain, Back Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Precision
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain focused on measuring Pain, Neurostimulation, Back pain, Chronic Pain
Eligibility Criteria
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.
Sites / Locations
- Comprehensive Pain Management and Rehabilitation
Outcomes
Primary Outcome Measures
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"
Secondary Outcome Measures
Full Information
NCT ID
NCT00399516
First Posted
November 13, 2006
Last Updated
March 7, 2012
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00399516
Brief Title
Effect of Pulse Width With Spinal Cord Stimulation
Official Title
The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Back Pain
Keywords
Pain, Neurostimulation, Back pain, Chronic Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Precision
Primary Outcome Measure Information:
Title
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
Description
Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Time Frame
Within 6 months post-implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Yearwood, MD
Organizational Affiliation
Comprehensive Pain and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Pain Management and Rehabilitation
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
12. IPD Sharing Statement
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Effect of Pulse Width With Spinal Cord Stimulation
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