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

NCT ID: NCT00443781

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PD and F.A.D. diagnostic testing

Group Type: OTHER

functional anesthetic discography

Intervention Type: 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.

provocative discography

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• 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.

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spine LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ray M Baker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Rick D Guyer, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Back Institute, Plano, TX

Locations

The Spine and Neurosurgery Center

Huntsville, Alabama, United States

Spine Source

Beverly Hills, California, United States

Pacific Spine Clinic

Escondido, California, United States

UCSD Orthopaedic Surgery

San Diego, California, United States

Emory Orthopaedics & Spine Center

Atlanta, Georgia, United States

Hanover Orthopaedic Associates, Inc.

Hanover, Pennsylvania, United States

Texas Back Institute

Plano, Texas, United States

East Texas Medical Center

Tyler, Texas, United States

Evergreen Surgical Center

Kirkland, Washington, United States

Milwaukee Neurological Institute

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

SP0603

Identifier Type: -

Identifier Source: org_study_id