Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

Withdrawn before enrolling · Not applicable

Conditions studied: Chronic Low Back Pain

In brief

Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting

Key facts

Study ID

NCT03658018

Run by

Relievant Medsystems, Inc.

People needed

0

Starts

2019-01-02

Expected to finish

2020-07-12

Last updated by the study team

2019-08-15

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Skeletally mature subjects age 25-70 years, inclusive
• Chronic lower back pain for at least six months
• Failure to respond to at least six months of non-operative conservative management
• Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
• Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1

You may not qualify if…

• Radicular pain by history or evidence of pain neurological deficit within the past one year.
• Previous surgery performed on the lumbar spine
• Current or history of symptomatic spinal stenosis
• Current or history of osteoporotic or tumor-related vertebral body compression fracture
• Current or history of vertebral cancer or spinal metastasis
• Current or history of spinal infection
• Metabolic bone disease
• BMI greater or equal to 40
• Any radiographic evidence of other important back pathology
• MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
• Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
• Subjects who are bed bound
• Demonstrates 3 or more Waddell's signs of Inorganic Behavior
• Any evidence of current systemic infection

Where it is running

• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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