Facet Joint SyndromeHIFU-FACETNCT05436873
MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:
A study testing MR-HIFU in people with Facet Joint Syndrome, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Patients suffering from facet-joint-syndrome associated with lower-back pain will be treated with MRI-guided High Intensity Focused Ultrasound thermal therapy for pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet Joint Syndrome
- What is being tested?
- MR-HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jun 2022to Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- chronic low back pain
- clinical diagnosis of Lumbar Facet Joint Syndrome
- eligible for MRI and MR-HIFU session
- eligible for general anaesthesia
- intact skin and soft tissue over treatment zone
- facet joint anatomy clearly identifiable
- patients must be able to discontinue all pain relief medication for a minimum of 48 hours prior to baseline assessment
- patients able to provide consent for the study
Who cannot join
- spinal implants
- treatment target zone < 10 mm from the skin
- pregnant female patients
- breastfeeding female patients
- body weight > 140 kg
- systemic and/or local infections
Show all 10Show fewer
- moderate to high grade of spinal instability
- MRI contrast agent contraindication
- any MRI-unsafe implant or pacemaker
- facet joint anatomy which is not targetable or reachable due to scars, surgical clips, implants, or prosthesis in the planned beam path of the ultrasound beam
Trial locations and contacts
1 site in 1 country.
Christian Krauss, PhD contact
Germany1 site, 1 recruiting
- Recruiting
Holger Gruell
Cologne, 50937
Holger Gruell, Prof
Christian Krauss, PhD, ChristianKrauss@uk-koeln.de
About this study
Official title: Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study
Patients suffering from facet-joint-syndrome associated with lower-back pain will be treated with MRI-guided High Intensity Focused Ultrasound thermal therapy for pain relief.
Read the detailed description
Patients with diagnosed facet-joint-syndrome are suffering from severe pain in the respective regions, mainly lower-back pain. Eligible patients will be treated with High Intensity Focused Ultrasound (HIFU) under MRI control. The control by MRI assures on the one hand the correct selection of area to be sonicated and monitors in parallel the temperature, reached in the target area. The aim is to thermally ablate facet joint and/or medial branch nerves at lumbar spine. Ablation is deemed to be feasible and successful if temperatures of at least 57°C are reached at the target. The entire procedure will be done under anaesthesia.
- Conditions
- Facet Joint Syndrome
- Being tested
- MR-HIFU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-HIFUDevice
MRI guided High Intensity Focused Ultrasound sonication.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This is a single arm study Receives: Device: MR-HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: planned temperature (57°C) achieved at target area of sonication
Temperatures achieved at the intended treatment location during MR-HIFU treatments
Measured: treatment day (4 hours)
Secondary outcomes (4)
safety of entire procedure
Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system
Measured: 180 days
Pain reduction after study treatment
pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication
Measured: 180 days
change in Quality of Life (QoL) assessed via Quality of Life Questionnaire
The change in QoL scores throughout study participation [as higher values, as better quality of Life]
Measured: 180 days
comparison of contrast in MRI before and after treatment
Qualitative analysis of the change in image tissue contrast in MRI images taken prior, during and after the treatment. This is a visual evaluation only.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start10 Jun 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There is only 1 treatment arm, as this is a feasibility study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Kourosh Zarghooni, PD, Principal investigator, Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436873
- Sponsor's protocol ID
- Uni-Koeln-4473
- Acronym
- HIFU-FACET
- Status last verified
- Sep 2022
- First submitted
- 24 Jun 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study
- ClinicalTrials.gov ID
- NCT05436873
- Acronym / sponsor ID
- HIFU-FACET / Uni-Koeln-4473
- Conditions
- Facet Joint Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 29 Jun 2022 (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.
Patients suffering from facet-joint-syndrome associated with lower-back pain will be treated with MRI-guided High Intensity Focused Ultrasound thermal therapy for pain relief.
Detailed description
Patients with diagnosed facet-joint-syndrome are suffering from severe pain in the respective regions, mainly lower-back pain. Eligible patients will be treated with High Intensity Focused Ultrasound (HIFU) under MRI control. The control by MRI assures on the one hand the correct selection of area to be sonicated and monitors in parallel the temperature, reached in the target area. The aim is to thermally ablate facet joint and/or medial branch nerves at lumbar spine. Ablation is deemed to be feasible and successful if temperatures of at least 57°C are reached at the target. The entire procedure will be done under anaesthesia.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is only 1 treatment arm, as this is a feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: MR-HIFUThis is a single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- chronic low back pain
- clinical diagnosis of Lumbar Facet Joint Syndrome
- eligible for MRI and MR-HIFU session
- eligible for general anaesthesia
- intact skin and soft tissue over treatment zone
Key exclusion criteria (10 listed)
- spinal implants
- treatment target zone < 10 mm from the skin
- pregnant female patients
- breastfeeding female patients
- body weight > 140 kg
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 |
|---|---|---|
| MR-HIFUMRI guided High Intensity Focused Ultrasound sonication. | Device | Treatment Arm |
Primary outcome
Feasibility: planned temperature (57°C) achieved at target area of sonication
Time frame: treatment day (4 hours)
Temperatures achieved at the intended treatment location during MR-HIFU treatments
4 secondary outcomes
safety of entire procedure
Time frame: 180 days
Pain reduction after study treatment
Time frame: 180 days
change in Quality of Life (QoL) assessed via Quality of Life Questionnaire
Time frame: 180 days
comparison of contrast in MRI before and after treatment
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Cervical Medial Branch Block Versus Ipsilateral Cervical Erector Spinae Plane Block
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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.
Christian Krauss, PhD contact
Kourosh Zarghooni, PD principal investigator
Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-HIFU in people with Facet Joint Syndrome, run by Universitätsklinikum Köln at 1 site in Germany.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Sep 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Krauss, PhD (ChristianKrauss@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: planned temperature (57°C) achieved at target area of sonication (time frame: treatment day (4 hours)). 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 15 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.