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

Relievant Medsystems

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Standard Care; Device: Intracept System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03246061

CIP 0006

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 140 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

BVN Ablation

Active Comparator group

Description:

BVN ablation with continued standard care

Treatment:

Device: Intracept System

Standard Care Control

Active Comparator group

Description:

Continue with non-surgical standard care

Treatment:

Other: Standard Care