Examination of Nociscan Impact on Low Back Pain Surgical Outcomes
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAclarion
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
Subject intends to undergo instrumented surgical treatment in the lumbar spinal disc for their lower back pain, independent of this research protocol;
Subject is to be treated with FDA-cleared or FDA-approved devices independent of this research protocol;
Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
Disqualifiers
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);
Grade 3 Spondylolisthesis (Grade 1 or Grade 2 is allowed)
Pars fracture, at the involved level
Spondylolysis
Trial population
Patients presenting with back pain potentially caused by lumbar degenerative spine disease. Patients must be indicated for surgical treatment of their low back pain. Patients must also meet all study inclusion criteria and none of the study exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fusion or TDR determined by investigator.
Procedure/SurgeryThe surgical treatment will be decided by the treating investigator based on their clinical judgement.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Blinded-to-NOCISCAN1 intervention
Group B: Unblinded-to-NOCISCAN1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 12 monthsSecondary outcomes
1
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.
Time frame
From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)2
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.
Time frame
From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)3
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.
Time frame
Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)4
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.
Time frame
Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aclarion
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov