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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: functional anesthetic discography; Procedure: provocative discography

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • The Spine and Neurosurgery Center
  • California
    • Beverly Hills, California, United States, 90212
      • Spine Source
    • Escondido, California, United States, 92025
      • Pacific Spine Clinic
    • San Diego, California, United States, 92103
      • UCSD Orthopaedic Surgery
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory Orthopaedics & Spine Center
  • Pennsylvania
    • Hanover, Pennsylvania, United States, 17331
      • Hanover Orthopaedic Associates, Inc.
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Back Institute
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Surgical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Milwaukee Neurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)	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.	Approximately 2 hours per subject

Collaborators and Investigators

• Sponsor: Medtronic Spine LLC
• Investigators: Principal Investigator: Ray M Baker, MD, University of Washington; Principal Investigator: Rick D Guyer, MD, Texas Back Institute, Plano, TX

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 2, 2007
• First Submitted That Met QC Criteria: March 2, 2007
• First Posted (Estimate): March 6, 2007

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: low back pain, degenerative disc disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SP0603