Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

Relievant Medsystems

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: Intracept

Study type: Interventional

Funder types: Industry

Identifiers

NCT03266107

CIP 0007 and CIP 0008

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment

Experimental group

Description:

BVN Ablation

Treatment:

Device: Intracept