INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
CompletedNot applicableNCT03246061
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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, 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 details
- Official title
- INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
- Conditions
- Interventions
- Device: Intracept System
- Other: Standard Care
- Sponsor
- Relievant Medsystems, Inc.
- Start date
- 2017-08-24
- Primary completion
- 2019-01-18
- Sex
- All
- Age range
- from 25 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 18
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Skeletally mature subjects at least 25 years of age * Chronic lower back pain for at least 6 months * Failure to respond to at least 6 months of non-operative conservative management Exclusion Criteria: * Radicular pain * Current or history of spinal infection * Modic changes at vertebral bodies other than L3 to S1 * Contraindication to MRI * Pregnant, lactating or plan to become pregnant in next year * Has life expectancy of less than 2 years * Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03246061