Status:
TERMINATED
Spinal Cord Stimulation for Chronic and Intractable Back Pain
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are...
Detailed Description
Management of symptoms of chronic back pain and/or lumbar radiculopathy is often difficult and inadequate. Current treatment options include pharmacological treatments, physical therapy, nerve blocks,...
Eligibility Criteria
Inclusion
- Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment.
- Be 18 years of age or older.
- Be an appropriate candidate for the surgical procedures required for SCS implant.
- 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 had any back or spine surgery.
- Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery.
- Have any other chronic pain conditions likely to confound evaluation of study endpoints.
- Are a current substance abuser (including alcohol and illicit drugs).
- Have a significant psychiatric disorder.
- Have a condition currently requiring or likely to require the use of MRI or diathermy.
- Have an active implantable device.
- Are pregnant or lactating or planning to become pregnant in the next year.
- Have participated in any 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 :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00370695
Start Date
February 1 2006
End Date
July 1 2008
Last Update
December 17 2020
Active Locations (1)
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1
Huntley Pain Specialists
San Diego, California, United States, 92108