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Sponsored by: |
Boston Scientific Corporation |
---|---|
Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00370695 |
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 not candidates for surgery or who have chosen to seek alternative therapy.
Condition | Intervention | Phase |
---|---|---|
Back Pain |
Device: Precision Spinal Cord Stimulation System |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates |
Enrollment: | 15 |
Study Start Date: | February 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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, surgical interruption of the pain pathway, or back surgery. Many patients either do not have adequate pain management with conventional treatments or are not able to tolerate the treatments due to significant side effects. Similarly, many patients are either not candidates for surgical interventions, or are unwilling to undergo such procedures. Spinal cord stimulation has proven to be an effective treatment for patients with pain following a failed back surgery, and this study will investigate spinal cord stimulation as a treatment option for the treatment of chronic back pain in patients who have never had back surgery. A successful study outcome will establish spinal cord stimulation as a less-invasive treatment option to be considered prior to surgery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Huntley Pain Specialists | |
San Diego, California, United States, 92108 |
Principal Investigator: | Michael Huntley, MD | Huntley Pain Specialists |
Responsible Party: | Boston Scientific Corporation ( Lyn Pimentel, Clinical Project Manager ) |
Study ID Numbers: | SCS-03-05 |
Study First Received: | August 30, 2006 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00370695 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chronic back pain Intractable neuropathic back pain Lumbar radiculopathy Spinal cord stimulation |
Signs and Symptoms Radiculopathy Neurologic Manifestations Pain Back Pain |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations Pain Back Pain |