Facet Joint PainNCT05122611
Post Lumbar Radiofrequency Neurotomy Imaging
An observational study of Facet Joint Pain, run by FUSMobile Inc. at 1 site in Canada.
Trial summary
MRI imaging post radio frequency ablation procedure for facet arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet Joint Pain
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2020to 11 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients volunteering to receive an MRI scan with and without contrast following radiofrequency neurotomy treatment for chronic lumbar pain
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
- Patient with hypertension or diabetes that requires medication
- Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup)
- Patients who are claustrophobic or known adverse psychological reactions with previous MRI
Trial locations and contacts
1 site in 1 country.
About this study
MRI imaging post radio frequency ablation procedure for facet arthritis
Read the detailed 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
- Conditions
- Facet Joint Pain
- Being tested
- no intervention, imaging study only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, imaging study onlyOther
Imaging study only
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI imaging of the lumbar spine
MRI imaging of the lumbar spine
Measured: Up to 5 days after the RFA procedure (which was done before the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start26 Feb 2020
- Primary completion7 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUSMobile Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122611
- Sponsor's protocol ID
- RFMRI01
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Lumbar Radiofrequency Neurotomy Imaging
- ClinicalTrials.gov ID
- NCT05122611
- Acronym / sponsor ID
- RFMRI01
- Conditions
- Facet Joint Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FUSMobile Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MRI imaging post radio frequency ablation procedure for facet arthritis
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients volunteering to receive an MRI scan with and without contrast following radiofrequency neurotomy treatment for chronic lumbar pain
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, imaging study onlyImaging study only | Other | – |
Primary outcome
MRI imaging of the lumbar spine
Time frame: Up to 5 days after the RFA procedure (which was done before the study)
MRI imaging of the lumbar spine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
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Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facet Joint Pain, run by FUSMobile Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI imaging of the lumbar spine (time frame: Up to 5 days after the RFA procedure (which was done before the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.