Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain
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|ClinicalTrials.gov Identifier: NCT03255395|
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : April 2, 2019
AIM: To provide initial information on the efficacy (pain reduction) and safety of focused ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic pain.
PARTICIPANTS: The study will include 10 amputees (men/women age >18 years old) with chronic (>3 months) phantom/residual limb pain (NPS ≥ 4).
DESIGN: Patients potentially qualifying for the study will be offered an Informed Consent to sign prior to further evaluation. Those who accept will sign the informed consent, complete study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically, a complete medical history will be obtained to determine the patient's general health status, current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain scores will be established. If not performed within six months prior to the evaluation, a contrast MRI of the stump will be performed. Patients not meeting the study criteria will be exited from the study as screen failures and not be included in analyses. All qualifying patients will complete a baseline MRI exam on treatment day. Any patient not meeting study criteria at Imaging will be exited as screen failures.
After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment. These patients will then be followed for 6-months post-ExAblate treatment; the patients will complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after treatment to assess their pain status, their quality of life and safety. Data regarding dosage and frequency of analgesic intake for the management of post amputation NP will be collected. Relevant cost data will be collected in order to enable an assessment of the total cost of the procedure.
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain Residual Limbs Amputation||Device: Magnetic resonance-guided focused ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single group feasibility study|
|Masking:||None (Open Label)|
|Official Title:||Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain|
|Actual Study Start Date :||April 24, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Magnetic resonance-guided focused ultrasound (MRgFUS)
Ten amputees will recieve magnetic resonance-guided focused ultrasound (MRgFUS) treatment aimed to ablate neromas, which are beleived to cuase phantom / residual limb pain
Device: Magnetic resonance-guided focused ultrasound
Ten amputees wil recieve a magnetic resonance-guided focused ultrasound treatment aimed at ablating neuromas, which are believe to contribute to their phantom / residual limb pain
- Change from baseline in the average daily pain [ Time Frame: Up to 6 months ]Change from baseline in the average daily pain intensity, measured for 3 consecutive days, on the Numerical Pain Scale (NPS), an 11-point numeric rating scale.
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): NCT03255395
|Contact: Elon Eisenberg, Profemail@example.com|
|Rambam Health Care Campus||Recruiting|
|Principal Investigator: Elon Eisenberg|