Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: functional anesthetic discography; provocative discography
Intervention description: 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.
Intervention MeSH terms: Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: low back pain, degenerative disc disease

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.
    

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.

        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.