Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Not Applicable

Withdrawn

• Conditions: Chronic Low Back Pain
• Interventions: Device: Intracept System Ablation

• Registration Number: NCT03630133
• Lead Sponsor: Relievant Medsystems, Inc.

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2018-05-08
• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intracept System Ablation	Intracept System Ablation	Single Arm

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	6, 9, and 12 months	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.
Visual Analog Scale (VAS)	3, 6, 9, and 12 months	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.

Trial Locations

Locations (1)

Indiana Spine Group; 🇺🇸 Carmel, Indiana, United States