Status:
WITHDRAWN
Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Complex Regional Pain Syndrome
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to compare the efficacy of SCS using the Precision implantable neurostimulation device and conventional medical treatment (nerve blocks + physical therapy) in su...
Detailed Description
Standard medical treatment for moderate/severe chronic pain of Complex Regional Pain Syndrome (CRPS) is usually inadequate. Sympathetic nerve blocks with local anesthetics are commonly employed and in...
Eligibility Criteria
Inclusion
- Be diagnosed with chronic CRPS with intractable neuropathic pain of moderate to severe intensity within the last 3-6 months.
- Have failed initial treatment for CRPS, such as physical therapy alone, oral medications, and/or steroids.
- Be 18 years of age or older.
- Be an appropriate candidate for the surgical procedures required for SCS.
- 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 unsuccessful back or spine surgery that currently causes pain.
- Have had any treatment for CRPS other than physical therapy, oral medications, or steroids.
- Have any evidence of neurologic instability.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00414804
Start Date
December 1 2006
Last Update
February 15 2012
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