Post Lumbar Radiofrequency Neurotomy Imaging

NCT05122611 | Completed

• 1 other identifier: RFMRI01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

MRI imaging post radio frequency ablation procedure for facet arthritis

Conditions

Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

• MRI imaging of the lumbar spine

  MRI imaging of the lumbar spine

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

Interventions

no intervention, imaging study only OTHER

Imaging study only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients volunteering to receive an MRI scan with and without contrast following radiofrequency neurotomy treatment for chronic lumbar pain

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• FUSMobile Inc.: lead

Study Sites (1)

Silver Medical Group

Toronto, Ontario, M3H 5S4, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: November 17, 2021
• Study Start: February 26, 2020
• Primary Completion: January 7, 2021
• Study Completion: January 11, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)