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Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

WithdrawnNot applicableNCT03658018
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Interventions
  • Device: Intracept System Ablation
Sponsor
Relievant Medsystems, Inc.
Start date
2019-01-02
Primary completion
2019-07-12
Sex
All
Age range
from 25 Years to 70 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03658018