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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | This is a single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-HIFU | Device | MRI guided High Intensity Focused Ultrasound sonication. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Krauss, PhD | Contact | ChristianKrauss@uk-koeln.de | ||
| Holger Gruell, Prof. | Contact | +49221 | 5880 | Holger.Gruell@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Kourosh Zarghooni, PD | Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holger Gruell | Recruiting | Cologne | 50937 | Germany |
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There is only 1 treatment arm, as this is a feasibility study.
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| 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 |