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OpenTrials
Completed

NCT Number: NCT05122611

Post Lumbar Radiofrequency Neurotomy Imaging

MRI imaging post radio frequency ablation procedure for facet arthritis

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Silver Medical Group

Toronto, Ontario, M3H 5S4, Canada

About this study

This study is an imaging study. Following a radio frequency ablation procedure for facet arthritis low back pain the patient can join the imaging study.

During the study the patient undergo contrast enhanced MRI imaging of the lumbar spine Once the imaging is done the patient finishes the study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult male and females, legally able and willing to participate in the study
  • Able and willing to complete the research questionnaires and communicate with the investigator and research team
  • Patients who are scheduled to have bilateral or unilateral treatment by radiofrequency neurotomy for chronic lumbar pain.

Exclusion criteria

  • Pregnant or breastfeeding patient
  • Patients younger than 18
  • Patients unable to understand and complete the research questionnaires in English
  • Patient with any contraindication for MRI contrast agents - Patients with known intolerance or allergies to the MRI contrast agent (e.g., Gadovist) including advanced kidney disease
  • Patients with a pacemaker, implanted defibrillator or internal pacing wires.
  • Patient with mechanical heart valve
  • Patient with an aneurysm clip
  • Patient with eye surgery or injury involving a metallic object
  • Patient with ear surgery or implanted device to the ear
  • Patient with any implanted electrical, metallic or magnetic device such as implanted neurostimulator, implanted drug infusion pump or bone growth stimulator
  • Patient with any kind of prosthesis (Eye, Ear, Penile, limb), or any other metal in your body from surgery or injury
  • Patient with vascular clamp, filter, coil or stent
  • Pregnant or breast-feeding patient
  • Patient with anemia, liver disease or history of MRI contrast reaction
  • Patient with any known kidney disease, prior kidney surgery or on dialysis
  • Patient with hypertension or diabetes that requires medication
  • Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup)
  • Patients who are claustrophobic or known adverse psychological reactions with previous MRI

Treatment and study plan

no intervention, imaging study only

Other

Imaging study only

Primary outcomes

  1. MRI imaging of the lumbar spine

    Time frame: Up to 5 days after the RFA procedure (which was done before the study)

    MRI imaging of the lumbar spine

Sponsors and collaborators

Lead sponsor

FUSMobile Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2021
Registry last updated
Nov 17, 2021

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.

Published trials that share one or more normalized conditions with this study.