INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
Public ClinicalTrials.gov record NCT03246061. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment. The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.
Study identification
- NCT ID
- NCT03246061
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 25 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2017 (Actual)
- Primary completion
- Jan 18, 2019 (Actual)
- Completion
- Mar 5, 2024 (Actual)
- Last update posted
- Apr 2, 2024
2017 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | — |
| Barrow Brain and Spine | Phoenix | Arizona | 85048 | — |
| Keck Medicine of USC | Los Angeles | California | 90033 | — |
| Stanford Orthopaedic Surgery | Redwood City | California | 94063 | — |
| Denver Back Specialists | Greenwood Village | Colorado | 80111 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30329 | — |
| Drug Studies America | Marietta | Georgia | 30060 | — |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| St Luke's Hospital | Kansas City | Missouri | 64111 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Bassett Medical Center | Cooperstown | New York | 13326 | — |
| University of Rochester | Rochester | New York | 14618 | — |
| OrthoCarolina | Charlotte | North Carolina | 28207 | — |
| Clinical Investigations | Edmond | Oklahoma | 73013 | — |
| Pacific Sports and Spine | Eugene | Oregon | 97401 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Temple University | Philadelphia | Pennsylvania | 19147 | — |
| Precision Spine Center | Tyler | Texas | 75701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03246061, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03246061 live on ClinicalTrials.gov.