Status:
TERMINATED
Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00370773
Start Date
January 1 2006
End Date
February 1 2007
Last Update
September 5 2008
Active Locations (1)
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1
Comprehensive Pain & Rehabilitation
Daphne, Alabama, United States, 36526