Low Back PainCLARITYNCT06661850
Examination of Nociscan Impact on Low Back Pain Surgical Outcomes
An observational study of Low Back Pain, run by Aclarion at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Fusion or TDR determined by investigator.
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Jun 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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);
- Subject has a VAS back pain score of ≥40mm;
- 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;
- Subject has signed the IRB approved Informed Consent Form; and
- 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.
Who cannot join
- 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);
- 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°
Show all 11Show fewer
- Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst
- Lumbar kyphosis
- 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 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Andy Murillo contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Daniel Davidar, 6673067925, adavida1@jhmi.edu
Daniel Lubelski, MD
- Recruiting
Todd H. Lanman, M.D Inc
Beverly Hills, California, 90210
Nicole Phillips, 310-385-7766, research@spine.md
Todd Lanman, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Lidia Hrvojevic, 312-695-4463, lidia.hrvojevic@nm.org
Alpesh Patel, MD
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Boris Jancan, 847-570-3674, boris.jancan@endeavorhealth.org
Michael Musacchio, MD
- Recruiting
Scripps Health
La Jolla, California, 92037
Joy Biggers, 858-554-5273 ext. 354-5273, Biggers.joy@scrippshealth.org
Hani Malone, MD
- Recruiting
USC Keck Medical Center
Los Angeles, California, 90033
Edgar Martinez Sanchez, 323-442-5300, edgar.msanchez@med.usc.edu
Patrick Hsieh, MD
- Recruiting
University of Miami/ Jackson Health System
Miami, Florida, 33136
Adriana Saravia, 305-243-3048, a.saravia@med.miami.edu
Gregory Basil, MD
- Recruiting
Advocate Aurora Research Institute
Park Ridge, Illinois, 60068
Victor Arroyo, 847-723-7950, victor.arroyo@aah.org
Patrick Sugrue, MD
- Recruiting
University of Arizona
Phoenix, Arizona, 85004
Judy Galaz, 602-521-3300, Judy.Galaz@bannerhealth.com
Nicholas Theodore, MD
- Recruiting
Texas Back Institute
Plano, Texas, 75093
Shannon Rusch, 972-608-5181, srusch@texasback.com
Alexander Satin, MD
About this study
Official title: A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain
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.
- Conditions
- Low Back Pain
- Being tested
- Fusion or TDR determined by investigator.
- Keywords
- MR Spectroscopy, MRI, back pain, Nociscan
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fusion or TDR determined by investigator.Procedure or surgery
The surgical treatment will be decided by the treating investigator based on their clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Blinded-to-NOCISCAN | NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result. Receives: Procedure: Fusion or TDR determined by investigator. | |
| Unblinded-to-NOCISCAN | NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment. Receives: Procedure: Fusion or TDR determined by investigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (7)
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.
Measured: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From Baseline through study completion, 24-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start11 Jun 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aclarion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661850
- Sponsor's protocol ID
- Clarity
- Acronym
- CLARITY
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT06661850
- Acronym / sponsor ID
- CLARITY / Clarity
- Conditions
- Low Back Pain
- Keywords
- MR Spectroscopy, MRI, back pain, Nociscan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AclarionIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded-to-NOCISCAN | – | Procedure: Fusion or TDR determined by investigator.NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result. |
| Unblinded-to-NOCISCAN | – | Procedure: Fusion or TDR determined by investigator.NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (8 listed)
- 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);
- Subject has a VAS back pain score of ≥40mm;
Key exclusion criteria (11 listed)
- 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);
- 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 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fusion or TDR determined by investigator.The surgical treatment will be decided by the treating investigator based on their clinical judgement. | Procedure or surgery | Blinded-to-NOCISCAN, Unblinded-to-NOCISCAN |
Primary outcome
Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
Time frame: 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.
7 secondary outcomes
20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
Time frame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment
Time frame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Patient reported treatment satisfaction survey
Time frame: Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Patient-Reported Outcome Measurement Information System (PROMIS) 29 score
Time frame: 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)
Time frame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Absence of Secondary surgical intervention
Time frame: From Baseline through study completion, 24-Months
Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores
Time frame: From Baseline through study completion, 24-Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Related InfoLink provided by the sponsor.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andy Murillo contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Aclarion at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Bond (724-991-3369, rbond@aclarion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.