Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

— CLBP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03658018
• Other study ID #: CIP 0009
• Status: Withdrawn
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: July 12, 2020

Study information

• Verified date: March 2019
• Source: Relievant Medsystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 12, 2020
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Intracept System Ablation
Radiofrequency ablation using Intracept System

Locations

Country	Name	City	State
United States	Texas Back Institute	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Relievant Medsystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.	3 months
Secondary	Visual Analog Scale (VAS)	Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively.	3, 6, 9, and 12 months
Secondary	Oswestry Disability Index (ODI)	Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.	6, 9, and 12 months