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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
BVN Ablation	Intracept System	BVN ablation with continued standard care
Standard Care Control	Standard Care	Continue with non-surgical standard care

Primary Outcome Measures

Name	Time	Method
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)	3 months	Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.

Secondary Outcome Measures

Name	Time	Method
Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)	3 months post treatment / randomization	Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.

Locations (18): Keck Medicine of USC
🇺🇸
Los Angeles, California, United States
Denver Back Specialists
🇺🇸
Greenwood Village, Colorado, United States
Barrow Brain and Spine
🇺🇸
Phoenix, Arizona, United States
Stanford Orthopaedic Surgery
🇺🇸
Redwood City, California, 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
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
Clinical Investigations
🇺🇸
Edmond, Oklahoma, United States
OrthoCarolina
🇺🇸
Charlotte, North Carolina, United States
Penn State Milton S Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Pacific Sports and Spine
🇺🇸
Eugene, Oregon, United States
Temple University
🇺🇸
Philadelphia, Pennsylvania, United States
Precision Spine Center
🇺🇸
Tyler, Texas, United States
St Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Alabama Clinical Therapeutics
🇺🇸
Birmingham, Alabama, United States