Clinical trial NCT05436873: MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:
Official title: Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facet Joint Syndrome
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2022-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is only 1 treatment arm, as this is a feasibility study.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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
* 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

Primary outcomes:
measure: Feasibility: planned temperature (57°C) achieved at target area of sonication
timeFrame: treatment day (4 hours)
Secondary outcomes:
measure: safety of entire procedure
timeFrame: 180 days
measure: Pain reduction after study treatment
timeFrame: 180 days
measure: change in Quality of Life (QoL) assessed via Quality of Life Questionnaire
timeFrame: 180 days
measure: comparison of contrast in MRI before and after treatment
timeFrame: 180 days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Holger Gruell
Study officials:
affiliation: Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne
name: Kourosh Zarghooni, PD
role: PRINCIPAL_INVESTIGATOR
References: