. 2023 Jun 10;2(2):100256. doi: 10.1016/j.inpm.2023.100256

Table 1.

Inclusion and Exclusion Criteria

The primary inclusion and exclusion criteria for the two pooled studies are outlined below. Compared to the RCT study, the prospective single-arm cohort study allowed more lenient enrollment by eliminating the exclusion of patients using extended-release opioids and BMI >40.

Inclusion Criteria	Exclusion Criteria
• Skeletally mature patients with chronic (≥6 months) isolated lumbar back pain, who had not responded to at least 6 months of non-operative management • Type 1 or Type 2 Modic changes at one or more vertebral body for levels L3-S1 • Minimum ODI of 30 points (100-point scale) • Minimum VAS of 4 cm (10 cm scale) • Ability to provide informed consent, read and complete questionnaires	• MRI evidence of Modic changes at levels other than L3-S1 • Radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging) • Previous lumbar spine surgery (discectomy/laminectomy allowed if > 6 months prior to baseline and radicular pain resolved) • Symptomatic spinal stenosis (defined as the presence of neurogenic claudication and confirmed by imaging) • Metabolic bone disease, spine fragility fracture history, trauma/compression fracture, or spinal cancer • Spine infection, active systemic infection, bleeding diathesis • Radiographic evidence of other pain etiology • Disc extrusion or protrusion >5 mm • Spondylolisthesis >2 mm at any level • Spondylolysis at any level • Facet arthrosis/effusion correlated with facet-mediated LBP • Beck Depression Inventory >24 or 3 or more Waddell’s signs • Compensated injury or litigation • Currently taking extended-release opioids with addiction behaviors^a • BMI >40^a • Bedbound or neurological condition that prevents early mobility or any medical condition that impairs follow-up^a • Contraindication to MRI, allergies to components of the device, active implantable devices, pregnant or lactating

Inclusion Criteria

Exclusion Criteria

•
Skeletally mature patients with chronic (≥6 months) isolated lumbar back pain, who had not responded to at least 6 months of non-operative management
•
Type 1 or Type 2 Modic changes at one or more vertebral body for levels L3-S1
•
Minimum ODI of 30 points (100-point scale)
•
Minimum VAS of 4 cm (10 cm scale)
•
Ability to provide informed consent, read and complete questionnaires

•
MRI evidence of Modic changes at levels other than L3-S1
•
Radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging)
•
Previous lumbar spine surgery (discectomy/laminectomy allowed if > 6 months prior to baseline and radicular pain resolved)
•
Symptomatic spinal stenosis (defined as the presence of neurogenic claudication and confirmed by imaging)
•
Metabolic bone disease, spine fragility fracture history, trauma/compression fracture, or spinal cancer
•
Spine infection, active systemic infection, bleeding diathesis
•
Radiographic evidence of other pain etiology
- •
  Disc extrusion or protrusion >5 mm
- •
  Spondylolisthesis >2 mm at any level
- •
  Spondylolysis at any level
- •
  Facet arthrosis/effusion correlated with facet-mediated LBP
•
Beck Depression Inventory >24 or 3 or more Waddell’s signs
•
Compensated injury or litigation
•
Currently taking extended-release opioids with addiction behaviors^a
•
BMI >40^a
•
Bedbound or neurological condition that prevents early mobility or any medical condition that impairs follow-up^a
•
Contraindication to MRI, allergies to components of the device, active implantable devices, pregnant or lactating

Abbreviations: MRI - magnetic resonance imaging; ODI - Oswestry Disability Index; VAS - Visual Analogue Scale (average low back pain in past 7 days); mm - millimeters; BMI - body mass index.

Exclusion criteria for the INTRACEPT trial only.