Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain
CompletedNot applicableNCT03266107
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)
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
Study details
- Official title
- A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
- Conditions
- Interventions
- Device: Intracept
- Sponsor
- Relievant Medsystems, Inc.
- Start date
- 2018-02-14
- Primary completion
- 2020-02-17
- Sex
- All
- Age range
- from 25 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03266107