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Completed

NCT Number: NCT03246061

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Clinical Therapeutics, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracept System

Device

BVN ablation using radiofrequency energy

Standard care

Other

Non-surgical standard care

Primary outcomes

  1. Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)

    Time frame: 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 outcomes

  1. Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Relievant Medsystems, Inc.

Industry

Registry information

Official study title

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

Acronym: CLBP

Important dates

Study start
2017
Primary completion
2019
Study completion
2024
First posted
Aug 11, 2017
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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