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

Not Applicable

Recruiting

• Conditions: Facet Joint Syndrome
• Interventions: Device: MR-HIFU

• Registration Number: NCT05436873
• Lead Sponsor: Universitätsklinikum Köln

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.

Study Timeline

• Study Start: 2022-06-10
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	MR-HIFU	This is a single arm study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Holger Gruell; 🇩🇪 Cologne, Germany