Back to resultsComparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation
Primary Purpose
Back Pain
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Precision Spinal Cord Stimulation System
Sponsored by
About this trial
This is an interventional diagnostic trial for Back Pain focused on measuring Failed Back Surgery Syndrome, Back Pain, Chronic Pain, Spinal Cord Stimulation
Eligibility Criteria
Inclusion Criteria: Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome. Be an appropriate candidate for Spinal Cord Stimulation (SCS) and for the surgical procedures required for SCS. Have experienced significant though short-lived pain relief with local anesthetic injection. 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. Have any evidence of neurologic instability. Have any other chronic pain condition. Have a condition currently requiring or likely to require the use of MRI or diathermy. Have an active implantable device. Are pregnant or planning to become pregnant in the next year. Are a current substance abuser (including alcohol and illicit drugs). Have a significant psychiatric disorder. Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other trial during the duration of this study.
Sites / Locations
- Comprehensive Pain & Rehabilitation
Outcomes
Primary Outcome Measures
The primary objective of this study is to compare subthreshold intraspinal nerve root stimulation (INRS) with subthreshold and suprathreshold dorsal column stimulation (DCS).
The primary safety endpoint is incidence of adverse events.
Secondary Outcome Measures
The secondary objectives of this study are to assess the effect of different stimulation types on average pain and pain-related disability, and to assess the subjective comfort of paresthesia with different pulse widths.
Full Information
NCT ID
NCT00370773
First Posted
August 30, 2006
Last Updated
September 4, 2008
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00370773
Brief Title
Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation
Official Title
Treatment of Chronic Low Back Pain With Spinal Cord Stimulation: Comparison of Subthreshold Intraspinal Nerve Root Stimulation With Subthreshold and Suprathreshold Dorsal Column Stimulation and a Secondary Study of the Effect of Pulse Width
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Slow Enrolling
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will systematically evaluate the programming parameters of the Precision Spinal Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side effects.
Detailed Description
This study will investigate the efficacy of subthreshold intraspinal nerve root stimulation (INRS) in treating back pain. The efficacy of this strategy will be tested against dorsal column stimulation (DCS), the commonly-accepted technique for spinal cord stimulation. DCS will be tested at subthreshold and suprathreshold (perceptible) amplitudes. A substudy will involve patients who prefer suprathreshold DCS over INRS and subthreshold DCS. Its purpose is to systematically assess the pain relief afforded by a number of programs with different pulse widths. The overall purpose of this study is to investigate methods of making pain relief via electrical stimulation more comfortable by either using subthreshold amplitudes or by adjusting the pulse width of perceptible stimulation to a more pleasing range.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Failed Back Surgery Syndrome, Back Pain, Chronic Pain, Spinal Cord Stimulation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Precision Spinal Cord Stimulation System
Primary Outcome Measure Information:
Title
The primary objective of this study is to compare subthreshold intraspinal nerve root stimulation (INRS) with subthreshold and suprathreshold dorsal column stimulation (DCS).
Time Frame
1 year
Title
The primary safety endpoint is incidence of adverse events.
Time Frame
Throughout Study
Secondary Outcome Measure Information:
Title
The secondary objectives of this study are to assess the effect of different stimulation types on average pain and pain-related disability, and to assess the subjective comfort of paresthesia with different pulse widths.
Time Frame
1 year
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.
Be an appropriate candidate for Spinal Cord Stimulation (SCS) and for the surgical procedures required for SCS.
Have experienced significant though short-lived pain relief with local anesthetic injection.
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.
Have any evidence of neurologic instability.
Have any other chronic pain condition.
Have a condition currently requiring or likely to require the use of MRI or diathermy.
Have an active implantable device.
Are pregnant or planning to become pregnant in the next year.
Are a current substance abuser (including alcohol and illicit drugs).
Have a significant psychiatric disorder.
Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other trial during the duration of this study.
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 & Rehabilitation
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation
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