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出境医 / 临床实验 / NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study

NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study

Study Description
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.

Condition or disease Intervention/treatment
Lumbar Disc Disease Other: NOCISCAN-LS Disc MR Spectroscopy

Study Design
Layout table for study information
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
Arms and Interventions
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)

Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) to assess the intensity of pain [ Time Frame: 2 years ]
    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

  2. Demonstrate correlation of NOSCISCORE results to Provocative Discography +/- results in subset of study subjects that receive pre-operative provocative discogram [ Time Frame: 24 months ]
    Compare NOCISCORE results for Provocative discography positive discs versus Provocative discography negative discs in study subjects receiving pre-operative discogram


Eligibility Criteria
Layout table for eligibility information
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
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
Criteria

Inclusion Criteria:

  1. Has history consistent with degenerative disc disease as noted by back pain of discogenic origin with or without leg pain
  2. Has one of more of the following conditions as documented by CT or MRI and plain X-rays:

    1. Modic changes
    2. High intensity zones in the annulus
    3. Loss of discogenic height
    4. Decreased hydration of the disc
  3. Has single level symptomatic degenerative involvement from L3 to S1 in which surgical treatment is indicated
  4. Skeletally mature male or female (non-pregnant) between 18 and 70 years of age
  5. Pre-operative score ≥ 40% on Oswestry Disability Index
  6. VAS back pain score ≥ 40 mm and that is greater than the VAS leg pain scores
  7. 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
  8. 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
  9. 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

Exclusion Criteria:

  1. Has primary diagnosis of spinal condition other than degenerative disc disease at the involved level;
  2. 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)
  3. Surgery planned at more than one level
  4. 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;
    • 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
  5. Radiographic evidence of lumbar disc herniation with extrusion
  6. Clinically significant spinal canal stenosis as assessed by the Investigator
  7. Any significant motor strength deficit in lower extremities
  8. Suspicion of Sacro Iliac and/ or Facet joint pain as the primary pain generator;
  9. 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
  10. Has active bacterial infection, either local or systemic and/or potential for bacteremia
  11. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin) during the past 5 years
  12. 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;
  13. Applicable exclusionary criteria for standard lumbar MRI exam;
  14. Has pending litigation, except where required by the insurer as condition of coverage;
  15. BMI > 40kg/m2
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Tejashree (Teju) S Malushte, MD,MS,MS 9493914125 tejumalushte@accelerant.com
Contact: Avi Sharma 3232445878 avi.sharma@accelerant.com

Locations
Layout table for location information
United States, Texas
Texas Back Institute Recruiting
Plano, Texas, United States, 75093
Contact: Donna Ohnmeiss       dohnmeiss@texasback.com   
Principal Investigator: Jack Zigler, MD         
Sponsors and Collaborators
Nocimed, LLC
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
 (submitted: July 10, 2019)
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
 (submitted: July 8, 2019)
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
 (submitted: July 10, 2019)
  • Visual Analog Scale (VAS) to assess the intensity of pain [ Time Frame: 2 years ]
    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
  • Demonstrate correlation of NOSCISCORE results to Provocative Discography +/- results in subset of study subjects that receive pre-operative provocative discogram [ Time Frame: 24 months ]
    Compare NOCISCORE results for Provocative discography positive discs versus Provocative discography negative discs in study subjects receiving pre-operative discogram
Original Secondary Outcome Measures
 (submitted: July 8, 2019)
  • Mean Oswestry Disability Index score [ Time Frame: 24 months ]
    Mean Oswestry Disability Index score changes at 3, 6 and 24 months post-operative follow-up for Match versus Miss Group subjects
  • Visual Analog Scale (VAS) [ Time Frame: 2 years ]
    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
  • NOCISCORE comparison [ Time Frame: 24 months ]
    Compare NOCISCORE results for Provocative discography positive discs versus Provocative discography negative discs in study subjects receiving pre-operative discogram
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
  • 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
    Intervention: 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
    Intervention: Other: NOCISCAN-LS Disc MR Spectroscopy
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
 (submitted: July 8, 2019)
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:

  1. Has history consistent with degenerative disc disease as noted by back pain of discogenic origin with or without leg pain
  2. Has one of more of the following conditions as documented by CT or MRI and plain X-rays:

    1. Modic changes
    2. High intensity zones in the annulus
    3. Loss of discogenic height
    4. Decreased hydration of the disc
  3. Has single level symptomatic degenerative involvement from L3 to S1 in which surgical treatment is indicated
  4. Skeletally mature male or female (non-pregnant) between 18 and 70 years of age
  5. Pre-operative score ≥ 40% on Oswestry Disability Index
  6. VAS back pain score ≥ 40 mm and that is greater than the VAS leg pain scores
  7. 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
  8. 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
  9. 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

Exclusion Criteria:

  1. Has primary diagnosis of spinal condition other than degenerative disc disease at the involved level;
  2. 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)
  3. Surgery planned at more than one level
  4. 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;
    • 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
  5. Radiographic evidence of lumbar disc herniation with extrusion
  6. Clinically significant spinal canal stenosis as assessed by the Investigator
  7. Any significant motor strength deficit in lower extremities
  8. Suspicion of Sacro Iliac and/ or Facet joint pain as the primary pain generator;
  9. 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
  10. Has active bacterial infection, either local or systemic and/or potential for bacteremia
  11. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin) during the past 5 years
  12. 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;
  13. Applicable exclusionary criteria for standard lumbar MRI exam;
  14. Has pending litigation, except where required by the insurer as condition of coverage;
  15. BMI > 40kg/m2
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tejashree (Teju) S Malushte, MD,MS,MS 9493914125 tejumalushte@accelerant.com
Contact: Avi Sharma 3232445878 avi.sharma@accelerant.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Nocimed, LLC
Study Sponsor Nocimed, LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Nocimed, LLC
Verification Date July 2019

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