SODA: Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: PD and F.A.D. diagnostic testing
|
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.
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) [Approximately 2 hours per subject]
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.
Eligibility Criteria
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.
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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.
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Subject states that he/she is willing to undergo lumbar spinal fusion, disc replacement, or other definitive treatment if eventual diagnosis supports such treatment.
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Physician believes that discography is clinically indicated for the purpose of surgical decision-making for the subject.
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Pre-treatment low back pain by numerical rating scale (NRS) score > 4 (measured as average in last 24 hours on a 0-10 scale).
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Pre-treatment Oswestry Disability Index (ODI) > 40 (0 - 100 scale).
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Subject states availability for all study visits.
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Subject is able to understand the risks and benefits of participating in the study and provides written informed consent.
Exclusion Criteria:
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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).
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Suspected painful disc degeneration (based on clinical examination and MRI findings) outside of L5/S1, L4/L5 or L3/L4 levels.
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MRI shows disc abnormalities (listed in Inclusion Criteria #3) at all 3 lower lumbar discs (L3/L4, L4/L5 and L5/S1).
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Abnormal neurologic exam attributable to lumbar disc disease, herniation, or lumbar stenosis.
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Back, buttock or pelvic pain suspected to be due to spinal stenosis, spinal fractures, infection, cancer, facet arthropathy or other hip or pelvis pathology.
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Schmorl's node or endplate disruption evident on MRI at L5/S1, L4/L5, or L3/L4.
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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.
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Any previous lumbar spine fusion or disc replacement.
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More than grade 1 spondylolisthesis as assessed by x-ray or MRI.
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Significant clinical comorbidity that may potentially interfere with data collection or follow-up (e.g., dementia, severe comorbid illness).
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History of major depression, psychosis or somatization disorder, or panic disorder.
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Allergy to any materials used in PD or F.A.D. devices, contrast, lidocaine, or bupivacaine.
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Any evidence of disc or systemic infection.
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Pregnant or child-bearing potential and not currently on adequate birth control method.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Spine and Neurosurgery Center | Huntsville | Alabama | United States | 35801 |
| 2 | Spine Source | Beverly Hills | California | United States | 90212 |
| 3 | Pacific Spine Clinic | Escondido | California | United States | 92025 |
| 4 | UCSD Orthopaedic Surgery | San Diego | California | United States | 92103 |
| 5 | Emory Orthopaedics & Spine Center | Atlanta | Georgia | United States | 30329 |
| 6 | Hanover Orthopaedic Associates, Inc. | Hanover | Pennsylvania | United States | 17331 |
| 7 | Texas Back Institute | Plano | Texas | United States | 75093 |
| 8 | East Texas Medical Center | Tyler | Texas | United States | 75701 |
| 9 | Evergreen Surgical Center | Kirkland | Washington | United States | 98034 |
| 10 | Milwaukee Neurological Institute | Milwaukee | Wisconsin | United States | 53233 |
Sponsors and Collaborators
- Medtronic Spine LLC
Investigators
- Principal Investigator: Ray M Baker, MD, University of Washington
- Principal Investigator: Rick D Guyer, MD, Texas Back Institute, Plano, TX
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP0603
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PD and F.A.D. Diagnostic Testing |
|---|---|
| Arm/Group Description | Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study. |
| Period Title: Overall Study | |
| STARTED | 62 |
| COMPLETED | 37 |
| NOT COMPLETED | 25 |
Baseline Characteristics
| Arm/Group Title | PD and F.A.D. Diagnostic Testing |
|---|---|
| Arm/Group Description | Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study. |
| Overall Participants | 62 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
61
98.4%
|
| >=65 years |
1
1.6%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
40.7
(9.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
36
58.1%
|
| Male |
26
41.9%
|
| Region of Enrollment (participants) [Number] | |
| United States |
62
100%
|
Outcome Measures
| Title | Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects which underwent Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) consist of 1 population (N=50). Subjects which underwent either PD, F.A.D. or neither diagnostic test consist of a second population (all subjects enrolled, N=62). This is a diagnostic study. No imputation technique was used. |
| Arm/Group Title | PD and F.A.D. Diagnostic Testing |
|---|---|
| Arm/Group Description | Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study. |
| Measure Participants | 50 |
| Measure discs | 66 |
| PD - Negative and F.A.D. - Negative |
18
|
| PD - Negative and F.A.D. - Positive |
7
|
| PD - Positive and F.A.D. - Negative |
25
|
| PD - Positive and F.A.D. - Positive |
16
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PD and F.A.D. Diagnostic Testing |
|---|---|---|
| Comments | Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | McNemar | |
| Comments | Exact test was used. | |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | PD and F.A.D. Diagnostic Testing | |
| Arm/Group Description | Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study. | |
All Cause Mortality |
||
| PD and F.A.D. Diagnostic Testing | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| PD and F.A.D. Diagnostic Testing | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/62 (1.6%) | |
| Musculoskeletal and connective tissue disorders | ||
| neck pain | 1/62 (1.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| PD and F.A.D. Diagnostic Testing | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/62 (16.1%) | |
| Gastrointestinal disorders | ||
| nausea | 2/62 (3.2%) | 2 |
| vomiting | 2/62 (3.2%) | 2 |
| Injury, poisoning and procedural complications | ||
| back injury | 1/62 (1.6%) | 1 |
| procedural pain | 1/62 (1.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| back pain | 3/62 (4.8%) | 3 |
| groin pain | 1/62 (1.6%) | 1 |
| muscle spasms | 1/62 (1.6%) | 1 |
| pain in extremity | 2/62 (3.2%) | 2 |
| Nervous system disorders | ||
| monoparesis | 1/62 (1.6%) | 1 |
| sciatica | 1/62 (1.6%) | 1 |
| syncope vasovagal | 1/62 (1.6%) | 1 |
| Psychiatric disorders | ||
| abnormal dreams | 1/62 (1.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
No publication, abstract, or presentation shall be submitted unless the multi-center report has been published. If report is not submitted within 24 months after completion, PI can present outcomes from their site. Proposed publications or presentations to be submitted to sponsor for review at least 60 days in advance. If proposed publication or presentation contains subject matter which is deemed to warrant intellectual property protection, sponsor may delay up to an additional 90 days.
Results Point of Contact
| Name/Title | Clinical Department |
|---|---|
| Organization | Medtronic Spine and Biologics |
| Phone | 1800-876-3133 ext 6068 |
| msbkclinicalresearch@medtronic.com |
- SP0603