Facet Joints; DegenerationNCT01788410
MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine
An observational study of Facet Joints; Degeneration and Neuropathy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet Joints; Degeneration, Neuropathy, Neuralgia
- What is being tested?
- Cryoablation under image guidance and MRI Seednet Cryotherapy System (Galil Medical)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential subjects must be 18 years of age and will be selected among patients who have a pain related to facet joint disease, nerve degeneration or compression. Subjects must benefit from a minimally invasive treatment option.
Who may be able to join
- 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
Who cannot join
- Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate <60ml/min, metal clips)
- Pregnant or breastfeeding woman are excluded from this research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Thomas Lee, M.D., 617-732-7260, tchlee@partners.org
Danielle Chamberlain, B.S, R.T.(R), 617-525-8596, dchamberlain1@partners.org
About this study
Official title: MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite
The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.
Read the detailed description
Nerve ablation is used therapeutically to produce temporary anesthesia and diagnostically to locate the source of pain. Ablation, or purposeful destruction of tissue, relieves facet joint pain and pain related to nerve damage by disabling pain-transmitting nerves. Cryoablation for pain management is particularly useful when other modalities are too difficult to perform or have a high incidence for complications or side effects.
Currently nerve ablation is performed with bupivacaine and alcohol, but MRI-guided cryoablation of nerves and facets may result in superior efficacy and longer relief. Cryotherapy techniques provide long term analgesia and help alleviate intractable pain for patients with facet joint pain and neuralgia.
Minimally invasive Magnetic Resonance (MR)-guided ablation of nerves and facets may lead to decreased procedure time and increased relief of pain due to cancer or nerve degeneration. With the advent of the Advanced Multimodality Image Guided Operating Suite (AMIGO) at the Brigham and Women's Hospital, we have exceptional capabilities for minimally invasive image-guided procedures, including different ablation techniques. The AMIGO suite is equipped with hardware that will keep the patient stationary while the Magnetic Resonance Imaging scanner moves to the patient. Additionally, the monitoring software within the AMIGO suite allows clinicians to instantaneously analyze the imaging information which significantly reduces the risk of injury to adjacent structures.
- Conditions
- Facet Joints; Degeneration, Neuropathy, Neuralgia
- Being tested
- Cryoablation under image guidance, MRI Seednet Cryotherapy System (Galil Medical)
- Keywords
- Cryoablation, Nerves, Facet joint, Pain, Neuralgia, Neuropathy, Image-guided
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation under image guidanceProcedure or surgery
Also called MRI Seed Net Cryotherapy Unit (Galil Medical), Siemens IMRIS
Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
MRI Seednet Cryotherapy System (Galil Medical)Device
Also called FDA Approved, Cryoablation under image guidance
Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation under image guidance | Patients with facet joint disease, or compressed or damaged nerve roots causing pain in the head, neck or spine. Procedures performed with MRI Seednet Cryotherapy System (Galil Medical). Receives: Procedure: Cryoablation under image guidance; Device: MRI Seednet Cryotherapy System (Galil Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliminating radicular pain or pain caused by spinal disease.
We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.
Measured: 1 month
Secondary outcomes (1)
Long term radicular pain relief
We are attempting to produce long-term pain relief through cryoablation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joints; DegenerationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas C. Lee, Brigham and Women's Hospital
- Investigators
- Thomas C Lee, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788410
- Sponsor's protocol ID
- 2012-P-002071
- Status last verified
- Aug 2023
- First submitted
- 7 Feb 2013
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite
- ClinicalTrials.gov ID
- NCT01788410
- Acronym / sponsor ID
- 2012-P-002071
- Conditions
- Facet Joints; Degeneration, Neuropathy, Neuralgia
- Keywords
- Cryoablation, Nerves, Facet joint, Pain, Neuralgia, Neuropathy, Image-guided
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.
Detailed description
Nerve ablation is used therapeutically to produce temporary anesthesia and diagnostically to locate the source of pain. Ablation, or purposeful destruction of tissue, relieves facet joint pain and pain related to nerve damage by disabling pain-transmitting nerves. Cryoablation for pain management is particularly useful when other modalities are too difficult to perform or have a high incidence for complications or side effects.
Currently nerve ablation is performed with bupivacaine and alcohol, but MRI-guided cryoablation of nerves and facets may result in superior efficacy and longer relief. Cryotherapy techniques provide long term analgesia and help alleviate intractable pain for patients with facet joint pain and neuralgia.
Minimally invasive Magnetic Resonance (MR)-guided ablation of nerves and facets may lead to decreased procedure time and increased relief of pain due to cancer or nerve degeneration. With the advent of the Advanced Multimodality Image Guided Operating Suite (AMIGO) at the Brigham and Women's Hospital, we have exceptional capabilities for minimally invasive image-guided procedures, including different ablation techniques. The AMIGO suite is equipped with hardware that will keep the patient stationary while the Magnetic Resonance Imaging scanner moves to the patient. Additionally, the monitoring software within the AMIGO suite allows clinicians to instantaneously analyze the imaging information which significantly reduces the risk of injury to adjacent structures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation under image guidance | – | Procedure: Cryoablation under image guidance, Device: MRI Seednet Cryotherapy System (Galil Medical)Patients with facet joint disease, or compressed or damaged nerve roots causing pain in the head, neck or spine. Procedures performed with MRI Seednet Cryotherapy System (Galil Medical). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects must be 18 years of age and will be selected among patients who have a pain related to facet joint disease, nerve degeneration or compression. Subjects must benefit from a minimally invasive treatment option.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate <60ml/min, metal clips)
- Pregnant or breastfeeding woman are excluded from this research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation under image guidanceAlso: MRI Seed Net Cryotherapy Unit (Galil Medical), Siemens IMRISObserving efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease. | Procedure or surgery | Cryoablation under image guidance |
| MRI Seednet Cryotherapy System (Galil Medical)Also: FDA Approved, Cryoablation under image guidanceObserving efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease. | Device | Cryoablation under image guidance |
Primary outcome
Eliminating radicular pain or pain caused by spinal disease.
Time frame: 1 month
We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.
1 secondary outcome
Long term radicular pain relief
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Brigham and Women's Hospital Tumor Ablation ProgramLink provided by the sponsor.
- AMIGO Operating Suite, Brigham and Women's Hospital (BWH)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas C Lee, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facet Joints; Degeneration and Neuropathy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Lee, MD ((617) 732-7260, tchlee@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliminating radicular pain or pain caused by spinal disease. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.