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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00205855 |
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.
Condition | Intervention | Phase |
---|---|---|
Chronic Pain Pain, Intractable Pain Back Pain Failed Back Surgery Syndrome |
Device: Stimulus Device: Precision |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System |
Enrollment: | 49 |
Study Start Date: | February 2003 |
Study Completion Date: | March 2005 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Alabama Pain Center | |
Huntsville, Alabama, United States, 35801 | |
United States, California | |
California Pain Medicine Centers | |
Los Angeles, California, United States, 90059 | |
Pacific Pain Treatment Center | |
San Francisco, California, United States, 94109 | |
United States, Montana | |
Yellowstone Neurological Associates | |
Billings, Montana, United States, 59101 | |
United States, New York | |
Northshore University Hospital | |
Syosset, New York, United States, 11791 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
Dallas Neurological Associates | |
Dallas, Texas, United States, 75231 | |
Texas Back Institute | |
Plano, Texas, United States, 75093 | |
River Oaks Pain Management | |
Houston, Texas, United States, 77027 |
Study Chair: | Kay Adair | Boston Scientific Corporation |
Responsible Party: | Boston Scientific ( Pam Phongpharnich, Sr. Clinical Research Associate ) |
Study ID Numbers: | CR-S-003 |
Study First Received: | September 13, 2005 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00205855 |
Health Authority: | United States: Food and Drug Administration |
Pain Chronic Pain Neurostimulation |
Pain, Intractable Signs and Symptoms Neurologic Manifestations Pain Back Pain |
Pathologic Processes Disease Syndrome Nervous System Diseases |