HIFU-FACET: MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm This is a single arm study |
Device: MR-HIFU
MRI guided High Intensity Focused Ultrasound sonication.
|
Outcome Measures
Primary Outcome Measures
- Feasibility: planned temperature (57°C) achieved at target area of sonication [treatment day (4 hours)]
Temperatures achieved at the intended treatment location during MR-HIFU treatments
Secondary Outcome Measures
- safety of entire procedure [180 days]
Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system
- Pain reduction after study treatment [180 days]
pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication
- change in Quality of Life (QoL) assessed via Quality of Life Questionnaire [180 days]
The change in QoL scores throughout study participation [as higher values, as better quality of Life]
- comparison of contrast in MRI before and after treatment [180 days]
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.
Eligibility Criteria
Criteria
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
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patients must be able to discontinue all pain relief medication for a minimum of 48 hours prior to baseline assessment
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patients able to provide consent for the study
Exclusion Criteria:
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spinal implants
-
treatment target zone < 10 mm from the skin
-
pregnant female patients
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breastfeeding female patients
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body weight > 140 kg
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systemic and/or local infections
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moderate to high grade of spinal instability
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MRI contrast agent contraindication
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any MRI-unsafe implant or pacemaker
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Holger Gruell | Cologne | Germany | 50937 |
Sponsors and Collaborators
- Universitätsklinikum Köln
- German Federal Ministry of Education and Research
Investigators
- Principal Investigator: Kourosh Zarghooni, PD, Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Uni-Koeln-4473