Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain

Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

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Key information

Conditions

Chronic Low-back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertebrogenic Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Flagstaff Bone & Joint, Flagstaff, Arizona, United States

About this study

The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
Signed a valid, IRB/EC-approved informed consent form.

Exclusion criteria

Meets any contraindications per locally applicable Instructions for Use (IFU).

Treatment and study plan

Intracept™ Intraosseous Nerve Ablation

Device

Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain

Primary outcomes

Change in Disability (Oswestry Disability Index (ODI) from Baseline

Time frame: 60-months post-procedure

The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Yamano

CONTACT

[email protected]

855-213-9890

Diane Keesey

CONTACT

[email protected]

855-213-9890

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: IMPROVE

Important dates

Study start: 2025
Primary completion: 2034
Study completion: 2034
First posted: Feb 14, 2025
Registry last updated: Jul 13, 2026

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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Recruiting