INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP

Completed · Not applicable

Conditions studied: Chronic Low Back Pain

In brief

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.

Key facts

Study ID

NCT03246061

Run by

Relievant Medsystems, Inc.

People needed

140

Starts

2017-08-24

Expected to finish

2024-03-05

Last updated by the study team

2024-04-02

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• Barrow Brain and Spine — Phoenix, Arizona, United States
• Keck Medicine of USC — Los Angeles, California, United States
• Stanford Orthopaedic Surgery — Redwood City, California, United States
• Denver Back Specialists — Greenwood Village, Colorado, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Drug Studies America — Marietta, Georgia, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• St Luke's Hospital — Kansas City, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Bassett Medical Center — Cooperstown, New York, United States
• University of Rochester — Rochester, New York, United States
• OrthoCarolina — Charlotte, North Carolina, United States
• Clinical Investigations — Edmond, Oklahoma, United States
• Pacific Sports and Spine — Eugene, Oregon, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Precision Spine Center — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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