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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
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This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded-to-NOCISCAN | NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result. |
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| Unblinded-to-NOCISCAN | NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fusion or TDR determined by investigator. | Procedure | The surgical treatment will be decided by the treating investigator based on their clinical judgement. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment | The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline. VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment | VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome. | From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) |
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Inclusion Criteria:
Exclusion Criteria:
Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);
Surgery is planned for more than 2 lumbar levels.
Subject has severe spinal canal stenosis as assessed by the Investigator;
Subject has a motor strength deficit(s) in lower extremities
Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including:
Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
Subject is contraindicated for a standard lumbar MRI exam
Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed
Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and/or may confound data
Subject has a BMI > 40
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Patients presenting with back pain potentially caused by lumbar degenerative disc disease. Patients may be symptomatic at one level or two levels. Patients must be indicated for surgical treatment of their discogenic low back pain. Patients must also meet all study inclusion criteria and none of the study exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Bond | Contact | 724-991-3369 | rbond@aclarion.com | |
| Andy Murillo | Contact | amurillo@aclarion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Todd H. Lanman, M.D Inc | Recruiting | Beverly Hills | California | 90210 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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| 20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment | VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome. | From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) |
| Patient reported treatment satisfaction survey | Patient Satisfaction survey is a self-reported questionnaire to measure the subject's satisfaction of the treatment under the protocol. | Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) |
| Patient-Reported Outcome Measurement Information System (PROMIS) 29 score | The PROMIS-29 v2. 0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. | Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) |
| Cumulative proportion of responders (CPRA) for 15 point Oswestry Disability Index (ODI) change (out of 100) | The Oswestry Disability Index (ODI) is a 10-item questionnaire that scores disability on a percentile scale from 0-100%. The ODI score is interpreted as follows: 0-20%: Minimal disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Crippling effects 80-100%: Completely disabled and bedbound | From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) |
| Absence of Secondary surgical intervention | Secondary surgical interventions may include revision, reoperation, removal or supplemental fixation at any level in the lumbar spine. | From Baseline through study completion, 24-Months |
| Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores | VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome. | From Baseline through study completion, 24-Months |
| Scripps Health | Recruiting | La Jolla | California | 92037 | United States |
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| USC Keck Medical Center | Recruiting | Los Angeles | California | 90033 | United States |
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| University of Miami/ Jackson Health System | Recruiting | Miami | Florida | 33136 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Advocate Aurora Research Institute | Recruiting | Park Ridge | Illinois | 60068 | United States |
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| Johns Hopkins Medicine | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Texas Back Institute | Recruiting | Plano | Texas | 75093 | United States |
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