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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
62
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 (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.
The Spine and Neurosurgery Center
Huntsville, Alabama, United States
Spine Source
Beverly Hills, California, United States
Pacific Spine Clinic
Escondido, California, United States
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.
Time frame: Approximately 2 hours per subject
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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