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

NCT00443781 | Completed Phase 4 Results

• 1 other identifier: SP0603
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Low Back Pain

Keywords

low back pain, degenerative disc disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PD and F.A.D. diagnostic testing

OTHER

Procedure: functional anesthetic discography; Procedure: provocative discography

Interventions

functional anesthetic discography PROCEDURE

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.

PD and F.A.D. diagnostic testing

provocative discography PROCEDURE

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.

PD and F.A.D. diagnostic testing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medtronic Spine LLC: lead

Study Sites (10)

The Spine and Neurosurgery Center

Huntsville, Alabama, 35801, United States

Location

Spine Source

Beverly Hills, California, 90212, United States

Location

Pacific Spine Clinic

Escondido, California, 92025, United States

Location

UCSD Orthopaedic Surgery

San Diego, California, 92103, United States

Location

Emory Orthopaedics & Spine Center

Atlanta, Georgia, 30329, United States

Location

Hanover Orthopaedic Associates, Inc.

Hanover, Pennsylvania, 17331, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Evergreen Surgical Center

Kirkland, Washington, 98034, United States

Location

Milwaukee Neurological Institute

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

There were 12 subjects which did not undergo both PD (Provocative Discography) and F.A.D. (Functional Anesthetic Discography) and therefore could not be included in the primary endpoint analysis (analyzable population for primary endpoint = 50/62).

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spine and Biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Study Officials

• Ray M Baker, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Rick D Guyer, MD

  Texas Back Institute, Plano, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 6, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 5, 2021
• Results First Posted: August 23, 2010

Record last verified: 2012-03

Locations

US (10)