Table 1

Inclusion/exclusion criteria for patients experiencing pain.

Inclusion Criteria
Male and nonpregnant female patients aged between 18 and 70 y. Institutional review board–approved informed consent obtained. Meet accepted criteria to be indicated for PD of the lumbar spine consistent with Practice Guidelines for Spinal Diagnostic and Treatment Procedures.9 Score ≥40% on the ODI. VAS score for back pain ≥4 cm. VAS score for leg pain: <4 cm OR <50% of VAS score for back pain PD was performed >6 wk but <6 mo prior to scheduled MRS or PD will be conducted within 1 mo after MRS.

Inclusion Criteria

Male and nonpregnant female patients aged between 18 and 70 y.
Institutional review board–approved informed consent obtained.
Meet accepted criteria to be indicated for PD of the lumbar spine consistent with Practice Guidelines for Spinal Diagnostic and Treatment Procedures.9
Score ≥40% on the ODI.
VAS score for back pain ≥4 cm.
VAS score for leg pain:
1. <4 cm OR
2. <50% of VAS score for back pain

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

Exclusion Criteria
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). 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. 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 Radiological evidence of lumbar disc herniation comprising extrusion. 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). Motor strength deficit in lower extremities. 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. Applicable exclusion criteria for standard lumbar MRI.

Exclusion Criteria

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).
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.
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
Radiological evidence of lumbar disc herniation comprising extrusion.
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).
Motor strength deficit in lower extremities.
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.
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.