N/A N=140 Randomized Treatment

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

Chronic Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT03246061 ↗

Enrolled (actual)

140

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) — -25.3; -4.4 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intracept System (Device); Standard Care (Other)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Relievant Medsystems, Inc.
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)	-25.3; -4.4	<0.001 sig
SECONDARY Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)	-3.46; -1.02	<0.001 sig

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03246061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.