The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.
The objectives of this study are to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment and to capture safety data of the procedure. The safety assessment measure is the incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment. Performance will be measure by assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the Numeric Rating Scale (NRS)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Ablation
Fondazione IRCCS Neurologico Carlo Besta
Milan, Italy
Performance Assessment-Pain Numeric Rating Scale
Assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level.
Time frame: 3 months
Performance Assessment-Pain Numeric Rating Scale
Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the pain Numeric Rating Scale (NRS). On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain. The questionnaire with higher score indicates a higher pain level.
Time frame: 6-12 months
Pain Disability Index
Change from baseline to 3 months post Exablate treatment for Physical Function/Disability measured using the Pain Disability Index (PDI). On a scale of 0 to 10, with 0 being no disability at all and 10 being the worst disability. The questionnaire evaluates the degree to which aspects of a patient's life are disrupted by pain.
Time frame: 3, 6, 12 Months
Pain Catastrophizing Scale
Change from baseline to 3 months post Exablate treatment for Emotional Function/Catastrophizing measured using the Pain Catastrophizing Scale (PCS). On a scale of 0 to 4, with 0 being not at all 4 being all the time. PCS questionnaire is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain).
Time frame: 3, 6, 12 Months
Beck Depression Inventory
Change from baseline to 3 months post Exablate treatment for Emotional Function/Depression using the Beck Depression Inventory (BDI-II). The assessment for detecting and intensity of depression and monitoring change over time after exablate treatment.
Time frame: 3, 6, 12 Months
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PROMIS Global Health Questionnaire
Change from baseline to 3 months post Exablate treatment for Impact of Pain/General Quality of Life measured using the PROMIS Global Health Questionnaire. On a scale of 1 to 5, with 1 being poor and 5 being excellent. PROMIS Global Health is a self-reported questionnaire to assess an individual's physical, mental, and social health.
Time frame: 3, 6, 12 Months
PROMIS Sleep Disturbance Questionnaire
Change from baseline to 3 months post Exablate treatment for Impact of Pain/Sleep using the PROMIS Sleep Disturbance Questionnaire. On a scale of 1 to 5, with 1 being very good and 5 very poor. PROMIS Sleep Disturbance is a validated, self-reported questionnaire to assess perceptions of sleep quality, sleep depth, and restoration associated with sleep.
Time frame: 3, 6, 12 Months
Adverse Events
Incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment
Time frame: 0 to 12 months