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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

1. Male or female, > 18 years old
a. Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 7 days prior to MR-HIFU treatment
b. and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial. A female patient is considered to be of childbearing potential unless she is above 50 years of age and naturally amenorrhoeic for = 2 years, or unless she is surgically sterile.
2. Patients with chronic LBP refractory to medical and/or physical treatment.
3. Clinical diagnosis of Lumbar Facet Joint Syndrome (radiologic signs of facet joint osteoarthritis and/or positive diagnostic infiltration of suspected facet joint levels)
4. Eligibility for MR imaging and MR-HIFU sessions
5. Eligibility for general anesthesia and/or sedation
6. Intact skin and soft tissue over treatment zone
7. Facet Joint Anatomy clearly identifiable, targetable, and reachable in MRI for treatment
8. Patients able to discontinue all current analgesic medications for a minimum 48-hour (or =5 half-lives of the particular analgesic, whichever is greater) prior to baseline assessment.
9. Patient able to provide consent for the study.

Exclusion Criteria

Exclusion Criteria
1. Spinal implants
2. Treatment target zone < 10mm from the skin
3. Pregnant female patients
4. Breastfeeding female patients
5. Body weight > 140 kg
6. Systemic and/or local infections
7. Moderate to high grade of spinal instability (Grade II – IV)
8. MRI contrast agent contraindications
9. Any MR-unsafe implant or pacemaker. Any MR-conditional implant that requires scanning with less than 3 Tesla or adjustments to the scan protocol.
10. Any other condition, which in the opinion of the investigators, would put the patient at increased risk or otherwise make the patients unsuitable for this study.
11. Participation in another clinical trial, simultaneously or within the last 30 days.
12. Facet Joint Anatomy, which is not targetable or reachable due to scars that cannot be protected, surgical clips, implants, or prosthesis in the planned path of the ultrasound beam.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Temperatures achieved at the intended treatment location during MR-HIFU treatments (descriptive statistics).

Secondary Outcome Measures

Name	Time	Method
•Safety: Evaluate the frequency and severity of adverse events associated with using the Sonalleve MR-HIFU System to treat facet joint syndrome.<br><br>•Pain reduction: Change in VAS score between baseline and at 1-, 3-, 7-, 14-, 30-, 60-, 90- and 180-days follow-up visits. <br><br>•Pain medication: Change in frequency, type, and dosage of pain medication intake between baseline and at 1-, 3-, 7-, 14-, 30-, 60-, 90- and 180-days follow-up visits.<br><br>•Patient’s quality of life: Change in ODI between baseline and at 3-, 7-, 14-, 30-, 60-, 90- and 180-days follow-up visits.<br><br>•MRI: Qualitative analysis of the change in image tissue contrast and morphology of facet joint, bone, and soft tissue between baseline and at 14-, 90- and 180-days follow-up visits. <br>