Low Back Pain
Conditions
Keywords
low back pain, degenerative disc disease
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.
Interventions
PROCEDUREfunctional 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.
PROCEDUREprovocative 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.
Sponsors
Medtronic Spine LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PD and F.A.D. Diagnostic Testing 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. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insurance not covered | 2 |
| Overall Study | Investigator terminated participation | 1 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | PD/FAD not done | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Unable to comply with study follow up | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | PD and F.A.D. Diagnostic Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Age, Continuous | 40.7 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 62 |
| serious Total, serious adverse events | 1 / 62 |
Outcome results
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.
Time frame: Approximately 2 hours per subject
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PD and F.A.D. Diagnostic Testing | Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) | PD - Negative and F.A.D. - Negative | 18 discs |
| PD and F.A.D. Diagnostic Testing | Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) | PD - Negative and F.A.D. - Positive | 7 discs |
| PD and F.A.D. Diagnostic Testing | Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) | PD - Positive and F.A.D. - Negative | 25 discs |
| PD and F.A.D. Diagnostic Testing | Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) | PD - Positive and F.A.D. - Positive | 16 discs |
Comparison: Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions.p-value: 0.002McNemar