Post Lumbar Radiofrequency Neurotomy Imaging

Facet Joint Pain Clinical Trial

Official title:

Post Lumbar Radiofrequency Neurotomy Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122611
• Other study ID #: RFMRI01
• Status: Completed
• Start date: February 26, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: August 2021
• Source: FUSMobile Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

MRI imaging post radio frequency ablation procedure for facet arthritis

Description:

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthralgia
• Facet Joint Pain

Intervention

Other:
• no intervention, imaging study only
Imaging study only

Locations

Country	Name	City	State
Canada	Silver Medical Group	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
FUSMobile Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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)