Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

Completed · Not applicable

Conditions studied: Chronic Low Back Pain

In brief

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

Key facts

Study ID

NCT03266107

Run by

Relievant Medsystems, Inc.

People needed

50

Starts

2018-02-14

Expected to finish

2020-02-17

Last updated by the study team

2020-12-22

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana Spine Group — Carmel, Indiana, United States
• Seton Spine and Scoliosis Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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