Lumbar Disc DiseaseNCT04015791
NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study
An observational study of Lumbar Disc Disease, run by Nocimed, LLC at 1 site in United States.
Trial summary
A prospective, double blinded, multi-center study to assess the validity and clinical utility of the pre-operative NOCISCAN-LS software in the identification of painful lumbar discs, and the correlation with improved surgical outcomes at 3, 6, 12 and 24 months (follow-up) following spine surgery in a single enrollment… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- NOCISCAN-LS Disc MR Spectroscopy
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 240 subjects that are approved and scheduled for surgery at a single level from L3 to S1 to treat chronic, severe, primary axial, discogenic, low back pain via maximum of 14 sites
Who may be able to join
- Has history consistent with degenerative disc disease as noted by back pain of discogenic origin with or without leg pain
- Has one of more of the following conditions as documented by CT or MRI and plain X-rays:
- Modic changes
- High intensity zones in the annulus
- Loss of discogenic height
- Decreased hydration of the disc
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- Has single level symptomatic degenerative involvement from L3 to S1 in which surgical treatment is indicated
- Skeletally mature male or female (non-pregnant) between 18 and 70 years of age
- Pre-operative score ≥ 40% on Oswestry Disability Index
- VAS back pain score ≥ 40 mm and that is greater than the VAS leg pain scores
- Patient has failed at least ≥6 months of non-operative treatment that may have included physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs
- In subject who receives pre-operative provocative discography (PD), the PD was performed more than 6 week prior to the scheduled NOCISCAN- LS Exam OR Is scheduled to be conducted after the Nociscan exam
- Subject is willing to sign an Institutional Review Board approved Informed Consent and HIPAA Authorization forms, and is physically and mentally able to complete study forms and otherwise willingly adhere to the requirements of the protocol in the opinion of the investigator
Who cannot join
- Has primary diagnosis of spinal condition other than degenerative disc disease at the involved level;
- Has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy +- laminectomy patients greater than 6 months postop are not excluded)
- Surgery planned at more than one level
- Radiographic evidence of clinically relevant lumbar vertebral abnormalities, including
- Greater than Grade 1 spondylolisthesis according to Meyerding classification at the involved level;
- Any posterior lumbar element insufficiency (e.g. Spondylolysis, pars fracture, or prior facet resection;
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- Lumbar scoliosis with a Cobb angle of greater than 11 degree
- Symptomatic kyphosis or flat black syndrome
- Evidence of prior fracture or trauma to the L1, L2,L3, L4 or L5 levels in either compression or burst; Note: Modic end plate changes will not be excluded
- Radiographic evidence of lumbar disc herniation with extrusion
- Clinically significant spinal canal stenosis as assessed by the Investigator
- Any significant motor strength deficit in lower extremities
- Suspicion of Sacro Iliac and/ or Facet joint pain as the primary pain generator;
- Has a condition that requires post-operative medications that interfere with fusion, such as immunosuppressive drugs, steroids or prolonged use of non-steroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation
- Has active bacterial infection, either local or systemic and/or potential for bacteremia
- Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin) during the past 5 years
- Chronic disease (other than degenerative disc disease), chronic pain syndrome (other than discogenic low back pain), or psychological dysfunction, which may , in the opinion of the Investigator compromise a subject's ability to comply with study procedures, and/ or may confound data;
- Applicable exclusionary criteria for standard lumbar MRI exam;
- Has pending litigation, except where required by the insurer as condition of coverage;
- BMI > 40kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Back Institute
Plano, Texas, 75093
Donna Ohnmeiss, dohnmeiss@texasback.com
Jack Zigler, MD
About this study
Official title: Clinical Evaluation of NOCISCAN-Lumbar Spine (LS) Disc MR Spectroscopy (MRS) for Diagnosis of Discogenic Low Back Pain and Correlation With Surgical Outcomes
A prospective, double blinded, multi-center study to assess the validity and clinical utility of the pre-operative NOCISCAN-LS software in the identification of painful lumbar discs, and the correlation with improved surgical outcomes at 3, 6, 12 and 24 months (follow-up) following spine surgery in a single enrollment arm of subjects with chronic symptomatic single level degenerative disc disease (DDD) at L3 to S1, but with two evaluation groups- Match Group and Miss Group,of subjects based on the association between the NOCISCORE results of treated and untreated disc levels.
- Conditions
- Lumbar Disc Disease
- Being tested
- NOCISCAN-LS Disc MR Spectroscopy
- Keywords
- lumbar disc disease, MR Spectroscopy, Nociscan
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOCISCAN-LS Disc MR SpectroscopyOther
Also called MR Spectroscopy (MRS)
The investigational Nociscan Suite is a software suite that works with existing high field MR systems and MRS pulse sequence via and optimized protocol to conduct MRS exam of lumbar discs. The software suite post-processes the NOCISCAN-LS disc MRS exam data to calculate ratios of spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that change with degeneration and pain
| Study group | Role | What they receive |
|---|---|---|
| Match Group | Surgery conducted at the disc level corresponding with the highest level of NOCISCORE value in the subject and that is classified as either NOCI + or NOCI mild Receives: Other: NOCISCAN-LS Disc MR Spectroscopy | |
| Miss Group | Surgery conducted at a disc that: (a) corresponds with a low relative NOCISCORE value in the subject and that is classifies as NOCI - or (b) excludes the disc level with the highest NOCISCORE value in the subject and that is classifies as NOCI+ or NOCI mild Receives: Other: NOCISCAN-LS Disc MR Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index Assessment to assess improvement in lumbar pain
Oswestry Disability Index is an index derived from Oswestry Low Back Pain Questionnaire used in several studies to quantify disability for low back pain. Each of the 10 items is scored from 0-5. The maximum score is therefore 50. This will be completed at 12 month follow up to see if there is an improvement of at least 15 points at 12 months Follow-up for Match Group versus Miss Group subjects. Mean Oswestry Disability Index score changes at 3, 6 and 24 months post-operative follow-up will be evaluated for Match versus Miss Group
Measured: 24 months
Secondary outcomes (2)
Visual Analog Scale (VAS) to assess the intensity of pain
Visual Analog Scale for pain is a validated tool used in determining the subjective level of pain in an individual. It will be completed at Mean Visual Analog Scale score changes for back pain at 3,6, 12 and 24 months post-op follow up for Match versus Miss Group
Measured: 2 years
Demonstrate correlation of NOSCISCORE results to Provocative Discography +/- results in subset of study subjects that receive pre-operative provocative discogram
Compare NOCISCORE results for Provocative discography positive discs versus Provocative discography negative discs in study subjects receiving pre-operative discogram
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Apr 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nocimed, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015791
- Sponsor's protocol ID
- NM005
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2019
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of NOCISCAN-Lumbar Spine (LS) Disc MR Spectroscopy (MRS) for Diagnosis of Discogenic Low Back Pain and Correlation With Surgical Outcomes
- ClinicalTrials.gov ID
- NCT04015791
- Acronym / sponsor ID
- NM005
- Conditions
- Lumbar Disc Disease
- Keywords
- lumbar disc disease, MR Spectroscopy, Nociscan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Nocimed, LLCUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 2019 (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.
A prospective, double blinded, multi-center study to assess the validity and clinical utility of the pre-operative NOCISCAN-LS software in the identification of painful lumbar discs, and the correlation with improved surgical outcomes at 3, 6, 12 and 24 months (follow-up) following spine surgery in a single enrollment arm of subjects with chronic symptomatic single level degenerative disc disease (DDD) at L3 to S1, but with two evaluation groups- Match Group and Miss Group,of subjects based on the association between the NOCISCORE results of treated and untreated disc levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Match Group | – | Other: NOCISCAN-LS Disc MR SpectroscopySurgery conducted at the disc level corresponding with the highest level of NOCISCORE value in the subject and that is classified as either NOCI + or NOCI mild |
| Miss Group | – | Other: NOCISCAN-LS Disc MR SpectroscopySurgery conducted at a disc that: (a) corresponds with a low relative NOCISCORE value in the subject and that is classifies as NOCI - or (b) excludes the disc level with the highest NOCISCORE value in the subject and that is classifies as NOCI+ or NOCI mild |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 240 subjects that are approved and scheduled for surgery at a single level from L3 to S1 to treat chronic, severe, primary axial, discogenic, low back pain via maximum of 14 sites
Key inclusion criteria (13 listed)
- Has history consistent with degenerative disc disease as noted by back pain of discogenic origin with or without leg pain
- Has one of more of the following conditions as documented by CT or MRI and plain X-rays:
- Has single level symptomatic degenerative involvement from L3 to S1 in which surgical treatment is indicated
- Skeletally mature male or female (non-pregnant) between 18 and 70 years of age
- Pre-operative score ≥ 40% on Oswestry Disability Index
Key exclusion criteria (20 listed)
- Has primary diagnosis of spinal condition other than degenerative disc disease at the involved level;
- Has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy +- laminectomy patients greater than 6 months postop are not excluded)
- Surgery planned at more than one level
- Radiographic evidence of clinically relevant lumbar vertebral abnormalities, including
- Radiographic evidence of lumbar disc herniation with extrusion
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 |
|---|---|---|
| NOCISCAN-LS Disc MR SpectroscopyAlso: MR Spectroscopy (MRS)The investigational Nociscan Suite is a software suite that works with existing high field MR systems and MRS pulse sequence via and optimized protocol to conduct MRS exam of lumbar discs. The software suite post-processes the NOCISCAN-LS disc MRS exam data to calculate ratios of spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that change with degeneration and pain | Other | Match Group, Miss Group |
Primary outcome
Oswestry Disability Index Assessment to assess improvement in lumbar pain
Time frame: 24 months
Oswestry Disability Index is an index derived from Oswestry Low Back Pain Questionnaire used in several studies to quantify disability for low back pain. Each of the 10 items is scored from 0-5. The maximum score is therefore 50. This will be completed at 12 month follow up to see if there is an improvement of at least 15 points at 12 months Follow-up for Match Group versus Miss Group subjects. Mean Oswestry Disability Index score changes at 3, 6 and 24 months post-operative follow-up will be evaluated for Match versus Miss Group
2 secondary outcomes
Visual Analog Scale (VAS) to assess the intensity of pain
Time frame: 2 years
Demonstrate correlation of NOSCISCORE results to Provocative Discography +/- results in subset of study subjects that receive pre-operative provocative discogram
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Disease, run by Nocimed, LLC at 1 site 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 13 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan Bond (650-241-1741, rbond@nocimed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index Assessment to assess improvement in lumbar pain (time frame: 24 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 29 Jul 2022.