MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:

Facet Joint Syndrome Clinical Trial

— HIFU-FACET  

Official title:

Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436873
• Other study ID #: Uni-Koeln-4473
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2022
• Source: Universitätsklinikum Köln
• Contact: Christian Krauss, PhD
• Email: ChristianKrauss[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Facet Joint Syndrome
• Syndrome

Intervention

Device:
• MR-HIFU
MRI guided High Intensity Focused Ultrasound sonication.

Locations

Country	Name	City	State
Germany	Holger Gruell	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Köln	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	safety of entire procedure	Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system	180 days
Secondary	Pain reduction after study treatment	pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication	180 days
Secondary	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
Secondary	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