INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 150
Summary
- Conditions
- Chronic Low Back Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: BVN Ablation vs Standard Care ControlMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 25 years and 70 years
- Gender
- Both males and females
Description
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up). Control arm subjects who were originally...
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up). Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
Tracking Information
- NCT #
- NCT03246061
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Steven R Garfin, MD Independent
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