Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source FUSMobile Inc.
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05952518 - PNS vs RFA for Facet Joint Pain N/A
Not yet recruiting NCT04542798 - CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting N/A
Completed NCT03323775 - Sensory Mapping of Lumbar Facet Joint Pain
Completed NCT05353465 - The Cervical Trident Study
Recruiting NCT05931653 - Multimodal PT With and Without Proprioceptive Training in Lumber FJS N/A
Terminated NCT02179476 - A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET N/A
Completed NCT01628939 - Association Between Clinical Signs and MRI Findings of the Lumbar Facet Joints N/A
Completed NCT06016127 - Cryoneurolysis for Facet Mediated Chronic Low Back Pain N/A
Recruiting NCT05961800 - Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks N/A
Recruiting NCT03534531 - Cortisone Shots for Neck Pain
Not yet recruiting NCT06236308 - TTAX03 for the Treatment of Lumbosacral Facet Joint Pain Phase 1
Recruiting NCT05949970 - The Lumbar Trident Study
Withdrawn NCT00896688 - Ultrasound Guided Diagnostic Cervical Medial Branch Block
Recruiting NCT03564418 - Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain. N/A
Terminated NCT03039296 - EuroPainClinics® Study IV (Prospective Observational Study)
Completed NCT05196919 - Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain Phase 2
Active, not recruiting NCT04786145 - Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain N/A
Completed NCT03444493 - The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation N/A
Completed NCT04152954 - Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain N/A
Completed NCT06157294 - Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain N/A