Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain (SODA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00443781
First received: March 2, 2007
Last updated: March 19, 2012
Last verified: March 2012
  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 anesthetic discography
Procedure: provocative discography
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain

Resource links provided by NLM:


Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:
  • Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) [ Time Frame: Approximately 2 hours per subject ] [ Designated as safety issue: Yes ]
    For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of >=2 Numerical Rating Scale (NRS) points AND >33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.


Enrollment: 62
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PD and F.A.D. diagnostic testing Procedure: functional anesthetic discography
Functional Anesthetic Discography (F.A.D.) involves the placement and anchoring of a small catheter into a disc. After placement, functional testing is performed, in which the subject elicits his/her back pain via functional maneuvers or postures. Local anaesthetic is then delivered into the target disc through the catheter and the effect on functional back pain is noted.
Procedure: provocative discography
Provocative discography (PD) has been used as a preoperative diagnostic tool for patients with back pain attributed to degenerative disc disease considering lumbar disc surgery. During PD, a clinically suspected disc is accessed with a needle and injected under pressure with radiopaque contrast dye. The subject rates his/her experience of pain for intensity and whether the pain is exactly the same as ("concordant") or different from ("not concordant" or "discordant") typical back pain.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  • 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
Spine Source
Beverly Hills, California, United States, 90212
Pacific Spine Clinic
Escondido, California, United States, 92025
UCSD Orthopaedic Surgery
San Diego, California, United States, 92103
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
Texas Back Institute
Plano, Texas, United States, 75093
East Texas Medical Center
Tyler, Texas, United States, 75701
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

Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00443781     History of Changes
Other Study ID Numbers: SP0603
Study First Received: March 2, 2007
Results First Received: June 23, 2010
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Spine LLC:
low back pain, degenerative disc disease

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014