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

Chronic Low Back Pain Clinical Trial

— CLBP  

Official title:

INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246061
• Other study ID #: CIP 0006
• Status: Completed
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: March 5, 2024

Study information

• Verified date: March 2024
• Source: Relievant Medsystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 5, 2024
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Intracept System
BVN ablation using radiofrequency energy

Other:
• Standard Care
Non-surgical standard care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Relievant Medsystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)	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.	3 months
Secondary	Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)	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.	3 months post treatment / randomization

External Links

•   INTRACEPT Study Website