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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD and F.A.D. diagnostic testing | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| functional anesthetic discography | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ray M Baker, MD | University of Washington | Principal Investigator |
| Rick D Guyer, MD | Texas Back Institute, Plano, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Spine and Neurosurgery Center | Huntsville | Alabama | 35801 | United States | ||
| Spine Source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| provocative discography | Procedure | 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. |
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| Beverly Hills |
| California |
| 90212 |
| United States |
| Pacific Spine Clinic | Escondido | California | 92025 | United States |
| UCSD Orthopaedic Surgery | San Diego | California | 92103 | United States |
| Emory Orthopaedics & Spine Center | Atlanta | Georgia | 30329 | United States |
| Hanover Orthopaedic Associates, Inc. | Hanover | Pennsylvania | 17331 | United States |
| Texas Back Institute | Plano | Texas | 75093 | United States |
| East Texas Medical Center | Tyler | Texas | 75701 | United States |
| Evergreen Surgical Center | Kirkland | Washington | 98034 | United States |
| Milwaukee Neurological Institute | Milwaukee | Wisconsin | 53233 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Number | discs | Approximately 2 hours per subject | discs | discs |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 62 | 10 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neck pain | Musculoskeletal and connective tissue disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders |
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| vomiting | Gastrointestinal disorders |
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| back injury | Injury, poisoning and procedural complications |
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| procedural pain | Injury, poisoning and procedural complications |
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| back pain | Musculoskeletal and connective tissue disorders |
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| groin pain | Musculoskeletal and connective tissue disorders |
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| muscle spasms | Musculoskeletal and connective tissue disorders |
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| pain in extremity | Musculoskeletal and connective tissue disorders |
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| monoparesis | Nervous system disorders |
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| sciatica | Nervous system disorders |
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| syncope vasovagal | Nervous system disorders |
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| abnormal dreams | Psychiatric disorders |
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There were 12 subjects which did not undergo both PD (Provocative Discography) and F.A.D. (Functional Anesthetic Discography) and therefore could not be included in the primary endpoint analysis (analyzable population for primary endpoint = 50/62).
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Department | Medtronic Spine and Biologics | 1800-876-3133 | 6068 | msbkclinicalresearch@medtronic.com |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Title | Measurements |
|---|---|
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| PD - Positive and F.A.D. - Positive |
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