Facet Joint Syndrome
Conditions
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.
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.
Interventions
DEVICEMR-HIFU
MRI guided High Intensity Focused Ultrasound sonication.
Sponsors
German Federal Ministry of Education and Research
Universitätsklinikum Köln
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
There is only 1 treatment arm, as this is a feasibility study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Contacts
Primary ContactChristian Krauss, PhD
Backup ContactHolger Gruell, Prof.
Outcome results
None listed