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MRI-Guided Cryoablation for Head, Neck, and Spine Pain

This study is observing a procedure called MRI-guided cryoablation to help people with pain in their head, neck, or spine. This pain can be caused by facet joint disease (problems with small joints in your spine) or by a damaged or compressed nerve. The procedure uses very cold temperatures to disable the nerves that send pain signals. Researchers are looking to see if this method, using the MRI Seednet Cryotherapy System (Galil Medical), can provide better and longer-lasting pain relief compared to current treatments. You might be able to join if you are 18 or older, have facet joint disease or nerve pain that could benefit from this type of procedure, and are able to give informed consent.

Study design
This is an observational study aiming to enroll 50 participants. It is not specified if it is a specific phase of a clinical trial.
What's involved
Participants must be able to adhere to the visit schedule, but the specific number or duration of visits is not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to eliminate pain, which will be measured at 1 month after the procedure.

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NCT01788410

MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine

Recruiting
Not specifiedAges 18+Observational
Brigham and Women's Hospital
~50 participants
Updated 2023-08-08 on ClinicalTrials.gov
What's tested:Cryoablation under image guidanceMRI Seednet Cryotherapy System (Galil Medical)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Eliminating radicular pain or pain caused by spinal disease.
Measured over 1 month

Conditions

Facet Joints; Degeneration
Neuropathy
Neuralgia

Explore related trials

Facet Joint DiseaseNerve Root Compression

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Thomas C Lee, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Thomas Lee, MD
[email protected]
(617) 732-7260
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must be willing and able to sign a written informed consent document.
Patients must have facet joint disease or pain due to a damaged or compressed nerve that would benefit from a minimally invasive image-guided procedure (i.e., adjacent to critical structures, better visualized under 3 Tesla MRI than CT)
Subjects must be able to adhere to the visit schedules and attend pre and post imaging.
Participants must be at least 18 years of age
Participants must have an estimated life expectancy of \>8 weeks in the opinion of the clinician.
Patients with radiculopathy must have the cause of pain confirmed by a nerve block within 3 months prior to ablation

Exclusion

Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate \<60ml/min, metal clips)
Pregnant or breastfeeding woman are excluded from this research.

What this trial measures

  • Eliminating radicular pain or pain caused by spinal disease.1 month

    We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.