Clinical trial NCT00443781: Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain
Official title: Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: low back pain, degenerative disc disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)
timeFrame: Approximately 2 hours per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Spine and Neurosurgery Center
state: Alabama
city: Beverly Hills
country: United States
facility: Spine Source
state: California
city: Escondido
country: United States
facility: Pacific Spine Clinic
state: California
city: San Diego
country: United States
facility: UCSD Orthopaedic Surgery
state: California
city: Atlanta
country: United States
facility: Emory Orthopaedics & Spine Center
state: Georgia
city: Hanover
country: United States
facility: Hanover Orthopaedic Associates, Inc.
state: Pennsylvania
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
city: Kirkland
country: United States
facility: Evergreen Surgical Center
state: Washington
city: Milwaukee
country: United States
facility: Milwaukee Neurological Institute
state: Wisconsin
Study officials:
affiliation: University of Washington
name: Ray M Baker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Back Institute, Plano, TX
name: Rick D Guyer, MD
role: PRINCIPAL_INVESTIGATOR
References: