MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study

Conditions
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Facet Joint Syndrome

Intervention / Treatment
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* Device: MR-HIFU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: There is only 1 treatment arm, as this is a feasibility study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>This is a single arm study | Device: MR-HIFU<br>* MRI guided High Intensity Focused Ultrasound sonication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: planned temperature (57°C) achieved at target area of sonication | Temperatures achieved at the intended treatment location during MR-HIFU treatments | treatment day (4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of entire procedure | Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system | 180 days | 
| Pain reduction after study treatment | pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication | 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] | 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. | 180 days |