Status:
COMPLETED
Effect of Pulse Width With Spinal Cord Stimulation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 anec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00399516
Start Date
November 1 2006
End Date
November 1 2007
Last Update
April 4 2012
Active Locations (1)
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1
Comprehensive Pain Management and Rehabilitation
Daphne, Alabama, United States, 36526