MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine
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| ClinicalTrials.gov Identifier: NCT01788410 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2013
Last Update Posted : March 8, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Facet Joints; Degeneration Neuropathy Neuralgia | Procedure: Cryoablation under image guidance Device: MRI Seednet Cryotherapy System (Galil Medical) |
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 Type : | Observational |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite |
| Study Start Date : | May 2013 |
| Estimated Primary Completion Date : | May 2019 |
| Estimated Study Completion Date : | May 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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).
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Procedure: 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.
Other Names:
Device: MRI Seednet Cryotherapy System (Galil Medical) Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
Other Names:
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- 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.
- Long term radicular pain relief [ Time Frame: 1 year ]We are attempting to produce long-term pain relief through cryoablation.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
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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 Criteria:
- Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate <60ml/min, metal clips)
- Pregnant or breastfeeding woman are excluded from this research.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788410
| Contact: Thomas Lee, MD | (617) 732-7260 | tchlee@partners.org | |
| Contact: Danielle Chamberlain, BS, RT(R) | 617-525-8596 | dchamberlain1@partners.org |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Thomas Lee, M.D. 617-732-7260 tchlee@partners.org | |
| Contact: Danielle Chamberlain, B.S, R.T.(R) 617-525-8596 dchamberlain1@partners.org | |
| Principal Investigator: Thomas C. Lee, M.D | |
| Principal Investigator: | Thomas C Lee, MD | Brigham and Women's Hospital |
Additional Information:
| Responsible Party: | Thomas C. Lee, MD, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01788410 History of Changes |
| Other Study ID Numbers: |
2012-P-002071 |
| First Posted: | February 11, 2013 Key Record Dates |
| Last Update Posted: | March 8, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Thomas C. Lee, Brigham and Women's Hospital:
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Cryoablation Nerves Facet joint Pain |
Neuralgia Neuropathy Image-guided |
Additional relevant MeSH terms:
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Neuralgia Pain Neurologic Manifestations Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |