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Research ArticleLumbar Spine

Establishing a Gold Standard for Noninvasive Identification of Painful Lumbar Discs: Prospective Comparison of Magnetic Resonance Spectroscopy vs Low-Pressure Provocation Discography

Matthew G. Gornet, James Peacock, Timothy Ryken, Francine W. Schranck, Robert K. Eastlack and Jeffrey C. Lotz
International Journal of Spine Surgery February 2024, 18 (1) 91-100; DOI: https://doi.org/10.14444/8574
Matthew G. Gornet
1 Orthopedic Center of St. Louis, MO, USA
MD
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James Peacock
2 Aclarion, Inc, Redwood City, CA, USA
BS, JD
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Timothy Ryken
3 Department of Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City, IA, USA
MD, MS
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Francine W. Schranck
4 SPIRITT Research, St. Louis, MO, USA
BSN
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Robert K. Eastlack
5 Department of Orthopedic Surgery, Scripps Clinic, San Diego, CA, USA
MD
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Jeffrey C. Lotz
6 Department of Orthopaedic Surgery, University of California, San Francisco, CA, USA
PHD
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  • For correspondence: Jeffrey.lotz@ucsf.edu
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    Figure 1

    Distributions (mean ± SD) of NOCISCORE Total and Normalized values for PD+ and PD− controls. PD, provocative discography

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    Figure 2

    SI-SCORES vs Pfirrmann Grades for 465 discs in 112 patients.

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    Figure 3

    Prospective surgical patient example 1. Two-level total disc replacement surgery was performed at L5-S1 and L4-L5 disc levels that were both NOCI+ and PD+, with an adjacent L3-L4 disc left untreated that was PD- but with an MRS-derived NOCISCORE that was classified as NOCImild. Midsagittal lumbar magnetic resonance imaging (left), NOCISCORE Totals for each evaluated disc level (middle), postprocessed magnetic resonance spectroscopy spectra for each disc (right), and NOCI±/mild color legend (far right). At 6 months, Oswestry Disability Index was unchanged (52 versus 54) while the visual analog scale for back pain was increased compared with the preoperative baseline (6.4 versus 5.6)

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    Figure 4

    Prospective surgical patient example 2. One-level total disc replacement surgery was performed at the L4-L5 disc level above a sacralized L5-S1 disc and was PD+ and NOCImild (as the highest NOCISCORE disc in the patient, NOCISCORE Normalized = 1). Midsagittal lumbar magnetic resonance imaging (left), NOCISCORE Totals for each evaluated disc level (middle), postprocessed magnetic resonance spectroscopy spectra for each disc (right), and NOCI±/mild color legend (far right). Surgery for this patient was considered a success by Oswestry Disability Index and visual analog scale at 6 (28, 2.1), 12 (12, 0.9), and 24 (22, 6) months.

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    Figure 5

    Prospective surgical patient example 3. Midsagittal lumbar magnetic resonance imaging (left), NOCISCORE totals for each evaluated disc level (middle), postprocessed magnetic resonance spectroscopy spectra for each disc (right), and NOCI±/mild color legend (far right).

Tables

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    Table 1

    Inclusion/exclusion criteria for patients experiencing pain.

    Inclusion Criteria
    1. Male and nonpregnant female patients aged between 18 and 70 y.

    2. Institutional review board–approved informed consent obtained.

    3. Meet accepted criteria to be indicated for PD of the lumbar spine consistent with Practice Guidelines for Spinal Diagnostic and Treatment Procedures.9

    4. Score ≥40% on the ODI.

    5. VAS score for back pain ≥4 cm.

    6. VAS score for leg pain:

      1. <4 cm OR

      2. <50% of VAS score for back pain

    1. PD was performed >6 wk but <6 mo prior to scheduled MRS or PD will be conducted within 1 mo after MRS.

    Exclusion Criteria
    1. Has had prior lumbar back surgery or intradiscal treatments at the index lumbar disc levels (diagnostic provocative or anesthetic discography or epidural steroid injections, sacroiliac injections, or facet joint injections are not excluded).

    2. Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breastfeeding, during the study period when scans will be performed.

    3. Diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except modic end-plate changes, which are not excluded), including:

      • Spondylolisthesis with >2 mm of translation, or with pars fracture, at the involved level

      • Spondylolysis

      • Lumbar scoliosis with a Cobb angle >15°

      • Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst

      • Lumbar kyphosis

    4. Radiological evidence of lumbar disc herniation comprising extrusion.

    5. Prior PD showing evidence of Grade 5 annular tear with contrast leakage (eg, per radiographic evidence and/or inability to maintain or increase pressure with increased injection volume).

    6. Motor strength deficit in lower extremities.

    7. Chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the principal investigator, compromise a patient’s ability to comply with study procedures and/or may confound data.

    8. Applicable exclusion criteria for standard lumbar MRI.

    • Abbreviations: MRI, magnetic resonance imaging; MRS, magnetic resonance spectroscopy; ODI, Oswestry Disability Index; PD, provocative discography; VAS, visual analog scale.

    • View popup
    Table 2

    Baseline characteristics of training and prospective patient cohorts.

    CharacteristicPatient Cohorts P a
    Training(n = 139)Prospective(n = 14)
    Age, y, mean (range)41.4 (20−65)34.5 (24−47)0.009
    Women, n (%)43 (31)2 (14)0.19
    Race/ethnic group, n (%)0.57
     Non-Hispanic137 (99)14 (100)
     White122 (88)13 (93)
     Black15 (11)1 (7)
    Body mass index, mean ± SD30.0 ± 6.231.5 ± 5.30.32
    Smoker, n (%)49 (35)1 (7)0.04
    Workers’ compensation, n (%)120 (86)10 (71)0.13
    Oswestry Disability Index score, mean ± SD56.5 ± 11.354.7 ± 14.10.65
    • ↵a Determined using t test.

    • View popup
    Table 3

    Distribution of NOCISCORE Total and Normalized values for different P/NP control groups in the prospective patient cohort.

    P/NP Discs n NOCISCORE TotalNOCISCORE Normalized
    MeanSD p (P vs NP)MeanSD p (P vs NP)
    P (PD+ & Dx+)77.62.7<0.0050.970.09<0.005
    P (PD+ only)67.22.7<0.050.960.09<0.005
    NP (PD-)123.02.90.420.41
    • Abbreviations: NP, nonpainful; P, painful; PD, provocative discography.

    • View popup
    Table 4

    Distribution of NOCISCORE Total and Normalized values for different P/NP disc control groups and between training and prospective cohorts.

    P/NP Disc ControlsPopulation n NOCISCORE TotalNOCISCORE Normalized
    MeanSDMeanSD
    P (PD+ & Dx+)(a) Training985.82.90.870.23
    (b) Prospective77.62.70.970.09
    p value (a) vs (b)0.14<0.05
    P (PD+ only)(a) Training855.82.90.870.22
    (b) Prospective67.22.70.960.09
    p value (a) vs (b)0.280.08
    NP (PD-)(a) Training1092.71.90.480.31
    (b) Prospective123.02.90.420.41
    p value (a) vs (b)0.780.62
    • Abbreviations: NP, nonpainful; P, painful; PD, provocative discography.

    • View popup
    Table 5

    Diagnostic accuracy metrics of magnetic resonance spectroscopy-based NOCISCORE results vs painful/nonpainful controls for prospective and training patient cohorts.

    Accuracy MetricsTrainingProspectiveAll Patients
    OverallNon-HerniatedHerniatedOverallNon-HerniatedHerniatedOverallNon-HerniatedHerniated
    % n % n % n % n % n % n % n % n % n
    Sensitivity81 %63/7883 %10/1280 %53/66100 %5/5100 %1/1100 %4/482 %68/8385 %11/1381 %57/70
    Specificity88 %84/9593 %66/7175 %18/2480 %8/1080 %8/10n/a0/088 %92/10591 %74/8175 %18/24
    PPV85 %63/7467 %10/1590 %53/5971 %5/733 %1/3100 %4/484 %68/8161 %11/1890 %57/63
    NPV85 %84/9997 %66/6858 %18/31100 %8/8100 %8/8n/a0/086 %92/10797 %74/7658 %18/31
    Overall Accuracy85 %147/17392 %76/8379 %71/9087 %13/1582 %9/11100 %4/485 %160/18890 %85/9480 %75/94
    NOCI+/–84 %173/20787 %83/9580 %90/11279 %15/1973 %11/15100 %4/483 %188/22685 %94/11081 %94/116
    NOCImild16 %34/20713 %12/9520 %22/11221 %4/1927 %4/150 %0/417 %38/22615 %16/11019 %22/116
    • Abbreviations: NA, not applicable; NPV, negative predictive value; PPV, positive predictive value.

    • View popup
    Table 6

    Distribution of magnetic resonance spectroscopy-derived SI-SCORES vs Pfirrmann Grades.

    Pfirrmann GradeNo.SI-SCORE t Test Between Pfirrmann Grades (P)
    MeanSDvs 2vs 3vs 4vs 5
    1950.840.140.20<0.005<0.0050.06
    22300.820.16-<0.005<0.0050.06
    31170.520.22--0.140.10
    4210.440.24---0.06
    520.080.11----
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1 Feb 2024
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Establishing a Gold Standard for Noninvasive Identification of Painful Lumbar Discs: Prospective Comparison of Magnetic Resonance Spectroscopy vs Low-Pressure Provocation Discography
Matthew G. Gornet, James Peacock, Timothy Ryken, Francine W. Schranck, Robert K. Eastlack, Jeffrey C. Lotz
International Journal of Spine Surgery Feb 2024, 18 (1) 91-100; DOI: 10.14444/8574

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Establishing a Gold Standard for Noninvasive Identification of Painful Lumbar Discs: Prospective Comparison of Magnetic Resonance Spectroscopy vs Low-Pressure Provocation Discography
Matthew G. Gornet, James Peacock, Timothy Ryken, Francine W. Schranck, Robert K. Eastlack, Jeffrey C. Lotz
International Journal of Spine Surgery Feb 2024, 18 (1) 91-100; DOI: 10.14444/8574
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Keywords

  • low back pain
  • magnetic resonance spectroscopy
  • pain biomarkers
  • lumbar disc surgery
  • discogenic
  • discogram
  • discography
  • diagnosis

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