Basivertebral Nerve Ablation With the Intracept Procedure

Prospective, Single-Arm, Cohort Study on Basivertebral Nerve Ablation With the Intracept Procedure

This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Intracept Procedure

Detailed Description

Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months.

Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Key West, Florida, United States, 33040
      • Neuro Spine and Pain Center of Key West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients ≥18 years of age
• Patients who have experienced chronic low back pain for ≥6 months.
• Patients who have not responded to at least 6 months of conservative care.
• Patients with Modic type 1 or 2 changes.

Exclusion Criteria:

• Patients with severe cardiac or pulmonary disease.
• Patients with active systemic infection or localized infection in the treatment area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Basivertebral Nerve Ablation; Intraosseous radiofrequency basivertebral nerve ablation	Device: Intracept Procedure; Intraosseous radiofrequency ablation of the basivertebral nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI) Change- 6 Months	Validated questionnaire of low back pain related disability. Compromised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored 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). Comparison of mean ODI baseline to 6 months.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI) Change-12 Months	Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored 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). Comparison of mean ODI baseline to 6 months. The minimally clinically important difference is a 15-point reduction from baseline.	12 Months
Visual Analog Scale (VAS)- 6 Months	Change in the mean visual analog scale (VAS) low back pain score from baseline to 6-months post treatment. VAS in a 10-point numeric scale with a 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 50% decrease in VAS from baseline.	6 Months
Visual Analog Scale (VAS)- 12 Months	Change in the mean visual analog scale (VAS) low back pain score from baseline to 12-months post treatment. VAS is a 10-point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimally clinically important difference is a 50% decrease in VAS from baseline.	12 Months
ODI Responder Rate- 6 Months	Number & percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 6 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally 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 is a 15-point reduction from baseline.	6 Months
ODI Responder Rate- 12 Months	Number & percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 12 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally 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 is a 15-point reduction from baseline.	12 Months
VAS Responder Rate- 6 Months	Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain at 6 months post treatment. VAS is a patient-reported 10-point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimally clinically important difference in VAS from baseline is a 50% reduction.	6 Months
VAS Responder Rate-12 Months	Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain at 12 months post treatment. VAS is a patient-reported 10-point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 50% reduction.	12 Months

Collaborators and Investigators

• Sponsor: Neuro Spine and Pain Center of Key West
• Investigators: Principal Investigator: William Schnapp, PhD, Owner

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic low back pain; Basivertebral nerve radiofrequency ablation; Vertebrogenic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 20223348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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