NCT05692440

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4 low-back-pain

Timeline
Completed

Started May 2021

Longer than P75 for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

4.7 years

First QC Date

January 11, 2023

Last Update Submit

March 19, 2024

Conditions

Low Back Pain

Keywords

Basivertebral nerve radiofrequency ablationChronic low back painVertebrogenic pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Oswestry Disability Index (ODI) Change-12 Months

    12 Months

  • Visual Analog Scale (VAS)- 6 Months

    6 Months

  • Visual Analog Scale (VAS)- 12 Months

    12 Months

  • ODI Responder Rate- 6 Months

    6 Months

  • ODI Responder Rate- 12 Months

    12 Months

  • +2 more secondary outcomes

Study Arms (1)

Basivertebral Nerve Ablation

OTHER

Intraosseous radiofrequency basivertebral nerve ablation

Device: Intracept Procedure

Interventions

Intracept ProcedureDEVICE

Intraosseous radiofrequency ablation of the basivertebral nerve

Basivertebral Nerve Ablation

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuro Spine and Pain Center of Key West

Key West, Florida, 33040, United States

Location

Related Publications (1)

  • Schnapp W, Schnapp M, Gottlieb J, Alexandre LC, Martiatu K, Delcroix GJ. Prospective cohort study of basivertebral nerve ablation for chronic low back pain in a real-world setting: 12 months follow-up. Interv Pain Med. 2024 Nov 25;3(4):100446. doi: 10.1016/j.inpm.2024.100446. eCollection 2024 Dec.

    PMID: 39655088DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Schnapp, PhD

    Owner

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

May 3, 2021

Primary Completion

January 1, 2026

Study Completion

June 1, 2026

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)