Low Back Pain
Conditions
Keywords
MR Spectroscopy, MRI, back pain, Nociscan
Brief summary
This study is looking into how useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan 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.
Interventions
PROCEDUREFusion or TDR determined by investigator.
The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Sponsors
Aclarion
MCRA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive); 2. Subject intends to undergo instrumented surgical treatment in the lumbar spinal disc for their lower back pain, independent of this research protocol; 3. Subject is to be treated with FDA-cleared or FDA-approved devices independent of this research protocol; 4. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100); 5. Subject has a VAS back pain score of ≥40mm; 6. Subject has failed at least ≥ 6 months of non-operative treatment (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator; 7. Subject has signed the IRB approved Informed Consent Form; and 8. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Exclusion criteria
1. 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); 2. 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: * Grade 3 Spondylolisthesis (Grade 1 or Grade 2 is allowed) * Pars fracture, at the involved level * Spondylolysis * Lumbar scoliosis with a Cobb angle of greater than 20° * Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst * Lumbar kyphosis 3. Subject is contraindicated for a standard lumbar MRI exam 4. 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 5. Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment | Baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment | From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) | 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. |
| 20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment | From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) | 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. |
| Patient reported treatment satisfaction survey | Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) | Patient Satisfaction survey is a self-reported questionnaire to measure the subject's satisfaction of the treatment under the protocol. |
| Patient-Reported Outcome Measurement Information System (PROMIS) 29 score | Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) | 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. |
| Cumulative proportion of responders (CPRA) for 15 point Oswestry Disability Index (ODI) change (out of 100) | From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months) | 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 |
| Absence of Secondary surgical intervention | From Baseline through study completion, 24-Months | Secondary surgical interventions may include revision, reoperation, removal or supplemental fixation at any level in the lumbar spine. |
| Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores | From Baseline through study completion, 24-Months | 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. |
Countries
United States
Contacts
CONTACTRyan Bond
CONTACTAndy Murillo
Outcome results
None listed