Status:
UNKNOWN
MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:
Lead Sponsor:
Universitätsklinikum Köln
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Facet Joint Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05436873
Start Date
June 10 2022
End Date
June 1 2024
Last Update
September 15 2022
Active Locations (1)
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1
Holger Gruell
Cologne, Germany, 50937