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Sponsored by: |
Medtronic Spine LLC |
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Information provided by: | Medtronic Spine LLC |
ClinicalTrials.gov Identifier: | NCT00443781 |
The primary objective of this study is to document and compare diagnostic test results and procedure safety in subjects undergoing both Functional Anaesthetic DiscographyTM (F.A.D.) and provocative discography (PD) and determine the appropriateness of the F.A.D. procedure data collection script for use in a larger clinical trial.
Condition | Intervention | Phase |
---|---|---|
Low Back Pain |
Procedure: Functional Anaesthetic Discography Procedure: provocative discography |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
(Note that DRAM consists of the Modified Zung Depression Score and the Modified Somatic Perception Questionnaire.)
United States, Alabama | |
The Spine and Neurosurgery Center | |
Huntsville, Alabama, United States, 35801 | |
United States, California | |
Pacific Spine Clinic | |
Escondido, California, United States, 92025 | |
UCSD Orthopaedic Surgery | |
San Diego, California, United States, 92103 | |
Spine Source | |
Beverly Hills, California, United States, 90212 | |
United States, Georgia | |
Emory Orthopaedics & Spine Center | |
Atlanta, Georgia, United States, 30329 | |
United States, Pennsylvania | |
Hanover Orthopaedic Associates, Inc. | |
Hanover, Pennsylvania, United States, 17331 | |
United States, Texas | |
East Texas Medical Center | |
Tyler, Texas, United States, 75701 | |
Texas Back Institute | |
Plano, Texas, United States, 75093 | |
United States, Washington | |
Evergreen Surgical Center | |
Kirkland, Washington, United States, 98034 | |
United States, Wisconsin | |
Milwaukee Neurological Institute | |
Milwaukee, Wisconsin, United States, 53233 |
Principal Investigator: | Ray M Baker, MD | University of Washington |
Principal Investigator: | Rick D Guyer, MD | Texas Back Institute, Plano, TX |
Study ID Numbers: | SP0603 |
Study First Received: | March 2, 2007 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00443781 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Central Nervous System Depressants Anesthetics Neurologic Manifestations |
Low Back Pain Pain Back Pain |
Signs and Symptoms Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants Anesthetics |
Neurologic Manifestations Low Back Pain Pain Central Nervous System Agents Back Pain Pharmacologic Actions |