Table 7.

Inclusion and exclusion criteria.

Inclusion criteria

Age between 18 to 70 years

Chronic LBP that is unresponsive to at least 3 months of conservative treatment (i.e., medication, intensive physical therapy, and local anesthetic infiltration in facet joints or medial branches) Pretreatment (baseline) back pain intensity of 4/10 or higher on a visual analog scale (VAS) Pretreatment (Baseline) Oswestry Disability Index Questionnaire (ODI) score of 30 or higher

Diagnosis of chronic LBP based on clinical and MRI data (modified Pfirrmann grade III–VII at one or two levels based on T2-weighted MRI)

Able to comply with the protocol physically and mentally, able to adhere to the requirements of the protocol, and willing to voluntarily sign the informed consent form.

Exclusion criteria

Radiculopathy resulting from nerve compression at screening or baseline, and unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low back pain as measured on a VAS at screening or baseline. Prior lumbar spine surgery

Prior lumbar vertebral body fracture

Severely herniated disc or spinal stenosis requiring surgery

Degenerative changes in the lumbar as determined by Modic Changes Type 3

Evidence of dynamic instability on lumbar flexion extension, and Grade 2 or higher spondylolisthesis at the target disc at screening.

Significant underlying neurological condition

Pregnant, breastfeeding, or planning to become pregnant within 2 years

Evidence of a spinal infection on an MRI

Uncontrolled hypertension, uncontrolled diabetes, and other serious systemic diseases, such as cancer, an autoimmune disease, blood disease, and kidney disease

LBP: low back pain; IVD: intervertebral disc; MRI: magnetic resonance imaging.