Status:
TERMINATED
Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Intractable Neuropathic Pain
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placemen...
Detailed Description
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neur...
Eligibility Criteria
Inclusion
- Be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for SCS, and have independently elected SCS as next line of therapy.
- 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 sensory loss in the low back or lower extremity as the primary complaint.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00399841
Start Date
November 1 2006
End Date
November 1 2008
Last Update
December 19 2020
Active Locations (1)
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1
Anesthesia Associates of Belleville
Belleville, Illinois, United States, 62220