Clinical trial NCT03246061: INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
Official title: INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Relievant Medsystems, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-11
Enrollment: 140
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: BVN Ablation vs Standard Care Control
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
timeFrame: 3 months
Secondary outcomes:
measure: Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)
timeFrame: 3 months post treatment / randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Barrow Brain and Spine
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medicine of USC
state: California
city: Redwood City
country: United States
facility: Stanford Orthopaedic Surgery
state: California
city: Greenwood Village
country: United States
facility: Denver Back Specialists
state: Colorado
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Kansas City
country: United States
facility: St Luke's Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Edmond
country: United States
facility: Clinical Investigations
state: Oklahoma
city: Eugene
country: United States
facility: Pacific Sports and Spine
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Tyler
country: United States
facility: Precision Spine Center
state: Texas
Study officials:
affiliation: Independent
name: Steven R Garfin, MD
role: PRINCIPAL_INVESTIGATOR
References: