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