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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Intracept System; Other: Standard Care

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
  • Arizona
    • Phoenix, Arizona, United States, 85048
      • Barrow Brain and Spine
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medicine of USC
    • Redwood City, California, United States, 94063
      • Stanford Orthopaedic Surgery
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Denver Back Specialists
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University School of Medicine
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St Luke's Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center
    • Rochester, New York, United States, 14618
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Clinical Investigations
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Sports and Spine
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19147
      • Temple University
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BVN Ablation; BVN ablation with continued standard care	Device: Intracept System; BVN ablation using radiofrequency energy
Active Comparator: Standard Care Control; Continue with non-surgical standard care	Other: Standard Care; Non-surgical standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Relievant Medsystems, Inc.
• Investigators: Principal Investigator: Steven R Garfin, MD, Independent

Publications and helpful links

Helpful Links

• INTRACEPT Study Website

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CIP 0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Trial results will be published at the completion of the trial
• IPD Sharing Time Frame: End of trial
• IPD Sharing Access Criteria: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes