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Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain (SODA)
This study is ongoing, but not recruiting participants.
First Received: March 2, 2007   Last Updated: October 23, 2008   History of Changes
Sponsored by: Medtronic Spine LLC
Information provided by: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00443781
  Purpose

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

MedlinePlus related topics: Anesthesia Back Pain
U.S. FDA Resources
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

Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:
  • The primary endpoint of the study is the difference in diagnostic test results between PD and F.A.D.

Estimated Enrollment: 100
Study Start Date: March 2007
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Age > 21.
  • Chronic axial low back pain without radicular pain for > six months, not responding to at least three months of non-surgical management under the direction of a physician.
  • One or two discs at L5/S1, L4/L5 or L3/L4 with abnormal findings by MRI, including any of the following: loss of disc hydration, loss of disc height, high intensity zone (HIZ), Modic changes at adjacent vertebral endplates, or herniation without nerve root compression.
  • Subject states that he/she is willing to undergo lumbar spinal fusion, disc replacement, or other definitive treatment if eventual diagnosis supports such treatment.
  • Physician believes that discography is clinically indicated for the purpose of surgical decision-making for the subject.
  • Pre-treatment low back pain by numerical rating scale (NRS) score > 4 (measured as average in last 24 hours on a 0-10 scale).
  • Pre-treatment Oswestry Disability Index (ODI) > 40 (0 - 100 scale).
  • Subject states availability for all study visits.
  • Subject is able to understand the risks and benefits of participating in the study and provides written informed consent.

Exclusion Criteria:

  • Known osteoporosis or osteopenia, metabolic bone disorder, or history of chronic steroid use (the equivalent of 7.5 milligrams of daily prednisone use for > 6 months).
  • Suspected painful disc degeneration (based on clinical examination and MRI findings) outside of L5/S1, L4/L5 or L3/L4 levels.
  • MRI shows disc abnormalities (listed in Inclusion Criteria #3) at all 3 lower lumbar discs (L3/L4, L4/L5 and L5/S1).
  • Abnormal neurologic exam attributable to lumbar disc disease, herniation, or lumbar stenosis.
  • Back, buttock or pelvic pain suspected to be due to spinal stenosis, spinal fractures, infection, cancer, facet arthropathy or other hip or pelvis pathology.
  • Schmorl's node or endplate disruption evident on MRI at L5/S1, L4/L5, or L3/L4.
  • Medical history, physical examination or radiographic evidence (e.g., disc height too narrow) to suggest that either PD or F.A.D. may not be technically feasible.
  • Any previous lumbar spine fusion or disc replacement.
  • More than grade 1 spondylolisthesis as assessed by x-ray or MRI.
  • Significant clinical comorbidity that may potentially interfere with data collection or follow-up (e.g., dementia, severe comorbid illness).
  • Distress and Risk Assessment Method (DRAM) according to the Main et al. criteria showing Zung Depression Scale scores >33 or MSPQ scores >12.

(Note that DRAM consists of the Modified Zung Depression Score and the Modified Somatic Perception Questionnaire.)

  • History of major depression, psychosis or somatization disorder, or panic disorder.
  • Allergy to any materials used in PD or F.A.D. devices, contrast, lidocaine, or bupivacaine.
  • Any evidence of disc or systemic infection.
  • Pregnant or child-bearing potential and not currently on adequate birth control method.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443781

Locations
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
Sponsors and Collaborators
Medtronic Spine LLC
Investigators
Principal Investigator: Ray M Baker, MD University of Washington
Principal Investigator: Rick D Guyer, MD Texas Back Institute, Plano, TX
  More Information

No publications provided

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

Study placed in the following topic categories:
Signs and Symptoms
Central Nervous System Depressants
Anesthetics
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009