Post Lumbar Radiofrequency Neurotomy Imaging

NCT ID: NCT05122611

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-26

Study Completion Date

2021-01-11

Brief Summary

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MRI imaging post radio frequency ablation procedure for facet arthritis

Detailed Description

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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

Conditions

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Facet Joint Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention, imaging study only

Imaging study only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Pregnant or breastfeeding patient
2. Patients younger than 18
3. Patients unable to understand and complete the research questionnaires in English
4. 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
5. Patients with a pacemaker, implanted defibrillator or internal pacing wires.
6. Patient with mechanical heart valve
7. Patient with an aneurysm clip
8. Patient with eye surgery or injury involving a metallic object
9. Patient with ear surgery or implanted device to the ear
10. Patient with any implanted electrical, metallic or magnetic device such as implanted neurostimulator, implanted drug infusion pump or bone growth stimulator
11. Patient with any kind of prosthesis (Eye, Ear, Penile, limb), or any other metal in your body from surgery or injury
12. Patient with vascular clamp, filter, coil or stent
13. Pregnant or breast-feeding patient
14. Patient with anemia, liver disease or history of MRI contrast reaction
15. Patient with any known kidney disease, prior kidney surgery or on dialysis
16. Patient with hypertension or diabetes that requires medication
17. Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup)
18. Patients who are claustrophobic or known adverse psychological reactions with previous MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FUSMobile Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Silver Medical Group

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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RFMRI01

Identifier Type: -

Identifier Source: org_study_id