Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Facet Joint Syndrome
- Sponsor
- Universitätsklinikum Köln
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Feasibility: planned temperature (57°C) achieved at target area of sonication
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Feasibility: planned temperature (57°C) achieved at target area of sonication
Time Frame: treatment day (4 hours)
Temperatures achieved at the intended treatment location during MR-HIFU treatments
Secondary Outcomes
- safety of entire procedure(180 days)
- Pain reduction after study treatment(180 days)
- change in Quality of Life (QoL) assessed via Quality of Life Questionnaire(180 days)
- comparison of contrast in MRI before and after treatment(180 days)