Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.

This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.

Inclusion Criteria:

• Skeletally mature subjects at least 25 years of age
• Chronic low back pain for at least 6 months
• Failure to respond to at least 6 months of non-operative conservative management
• Oswestry Disability Index (ODI) at least 30 points
• Modic changes Type 1 or 2

Exclusion Criteria:

• Current or history of vertebral cancer or spinal metastasis
• History of a fragility fracture
• Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
• Disc extrusion or protrusion