Neuropathic Pain, Peripheral Neuropathy
Conditions
Brief summary
The Exablate 4000 obtained CE Mark for the treatment of Neuropathic Pain in December 2012. The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain. 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.
Detailed description
The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.
Interventions
DEVICEExablate treatment
Exablate treatment for Neuropathic Pain
Sponsors
IRCCS Centro Neurolesi Bonino Pulejo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Men and women age 30 years or older * Subject undergoing an Exablate procedure for their planned neuropathic treatment per local institution standard of care * Subject has diagnosis of definite neuropathic pain (grading system IASP-NeupSIG) * Patient has a score of 6 or higher on the Numeric Rating Scale (NRS) * Subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes * Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation * Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
Exclusion criteria
* Subject diagnosed with a nociceptive chronic pain syndrome * Subject does not agree to participate or is unlikely to participate for the entirety of the study * Subject is currently participating in another clinical investigation with an active treatment arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Numerical Rating Score (NRS) | 72 h | The pain NRS consists of 1 question that will be asked by interviewing the subjects. The subjects will be asked to rate their average pain over the past 24 hours specific to the area(s) of the pain being treated on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level. |
Countries
Italy
Outcome results
None listed