| Condition or disease | Intervention/treatment |
|---|---|
| Lumbar Disc Disease | Other: NOCISCAN-LS Disc MR Spectroscopy |
| Study Type : | Observational |
| Estimated Enrollment : | 240 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | June 2020 |
| Estimated Study Completion Date : | June 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
|
Other: NOCISCAN-LS Disc MR Spectroscopy
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 Name: MR Spectroscopy (MRS)
|
|
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
|
Other: NOCISCAN-LS Disc MR Spectroscopy
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 Name: MR Spectroscopy (MRS)
|
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Has one of more of the following conditions as documented by CT or MRI and plain X-rays:
Exclusion Criteria:
Radiographic evidence of clinically relevant lumbar vertebral abnormalities, including
| Contact: Tejashree (Teju) S Malushte, MD,MS,MS | 9493914125 | tejumalushte@accelerant.com | |
| Contact: Avi Sharma | 3232445878 | avi.sharma@accelerant.com |
| United States, Texas | |
| Texas Back Institute | Recruiting |
| Plano, Texas, United States, 75093 | |
| Contact: Donna Ohnmeiss dohnmeiss@texasback.com | |
| Principal Investigator: Jack Zigler, MD | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 29, 2019 | ||||||||
| First Posted Date | July 11, 2019 | ||||||||
| Last Update Posted Date | August 6, 2019 | ||||||||
| Actual Study Start Date | June 1, 2019 | ||||||||
| Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
|
||||||||
| Original Primary Outcome Measures |
Oswestry Disability Index Assessment [ Time Frame: 12 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
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures |
|
||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | NOCISCAN-Lumbar Spine (LS) Clinical Evaluation 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 | ||||||||
| Brief 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 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| 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 | ||||||||
| Condition | Lumbar Disc Disease | ||||||||
| Intervention | Other: NOCISCAN-LS Disc MR Spectroscopy
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 Name: MR Spectroscopy (MRS)
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
240 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 2022 | ||||||||
| Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04015791 | ||||||||
| Other Study ID Numbers | NM005 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement |
|
||||||||
| Responsible Party | Nocimed, LLC | ||||||||
| Study Sponsor | Nocimed, LLC | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Nocimed, LLC | ||||||||
| Verification Date | July 2019 | ||||||||