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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
MRI guided High Intensity Focused Ultrasound sonication.
Holger Gruell
Cologne, Germany
RECRUITINGFeasibility: planned temperature (57°C) achieved at target area of sonication
Temperatures achieved at the intended treatment location during MR-HIFU treatments
Time frame: treatment day (4 hours)
safety of entire procedure
Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system
Time frame: 180 days
Pain reduction after study treatment
pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication
Time frame: 180 days
change in Quality of Life (QoL) assessed via Quality of Life Questionnaire
The change in QoL scores throughout study participation \[as higher values, as better quality of Life\]
Time frame: 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.
Time frame: 180 days
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