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

Low Back Pain Clinical Trial

— SODA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443781
• Other study ID #: SP0603
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2012
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory Orthopaedics & Spine Center	Atlanta	Georgia
United States	Spine Source	Beverly Hills	California
United States	Pacific Spine Clinic	Escondido	California
United States	Hanover Orthopaedic Associates, Inc.	Hanover	Pennsylvania
United States	The Spine and Neurosurgery Center	Huntsville	Alabama
United States	Evergreen Surgical Center	Kirkland	Washington
United States	Milwaukee Neurological Institute	Milwaukee	Wisconsin
United States	Texas Back Institute	Plano	Texas
United States	UCSD Orthopaedic Surgery	San Diego	California
United States	East Texas Medical Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spine LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 2 hours per subject