Facet Joint Pain Clinical Trial
Official title:
Post Lumbar Radiofrequency Neurotomy Imaging
NCT number | NCT05122611 |
Other study ID # | RFMRI01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 26, 2020 |
Est. completion date | January 11, 2021 |
Verified date | August 2021 |
Source | FUSMobile Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
MRI imaging post radio frequency ablation procedure for facet arthritis
Status | Completed |
Enrollment | 10 |
Est. completion date | January 11, 2021 |
Est. primary completion date | January 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Silver Medical Group | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
FUSMobile Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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