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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Facet Joint Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

There is only 1 treatment arm, as this is a feasibility study.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Treatment Arm

This is a single arm study

Group Type EXPERIMENTAL

MR-HIFU

Intervention Type DEVICE

MRI guided High Intensity Focused Ultrasound sonication.

Interventions

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MR-HIFU

MRI guided High Intensity Focused Ultrasound sonication.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No