The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external components. The system is intended for home care use. The chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. The stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
BlueWind Medical neurostimulator for the treatment of neuropathic pain
AZ Sint-Jan Brugge - Oostende AV
Bruges, Belgium
AZ Sint-Niklaas Hospital
Sint-Niklaas, Belgium
10 Military Clinical Hospital
Bydgoszcz, Poland
CenterMed Kraków Sp.z o.o.
Krakow, Poland
The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).
The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period
Time frame: 6 months
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation
VAS score assessment at baseline and follow up visits was performed in two ways; 1. Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days. 2. Point VAS score- the analysis was based on the VAS score measurement recorded during the baseline visit and following 30 minutes stimulation at all follow up visits.Pain assessment by Visual Analogue Scale (VAS) as compared to baseline, post system activation. Visual Analogue Scale (VAS) for Pain Scores on a scale \[0 - 10\], higher values represent a worse outcome.
Time frame: 1 Month, 3 Months, and 6 months post system activation
Clinical Success 6 Months Post Activation
Clinical success at 6 months post activation was further assessed by:Short-form McGill pain questionnaire. McGill pain questionnaire Scores on a scale Range \[0-60\] points, higher values represent a worse outcome.
Time frame: 1 Month, 3 Months, and 6 months post system activation
Clinical Success 6 Months Post Activation
Clinical success is defined as the effect of the BlueWind Reprieve System on the treatment of the following symptoms compared to baseline: \- Pain related medication consumption/day
Time frame: 6 months post activation
Clinical Success 6 Months Post Activation
Clinical success was further assessed by: Quality of life questionnaire (SF-36 Health Survey) SF-36 Health Survey Scores on a scale \[0 - 100\], higher values represent a better outcome.
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Time frame: 1 Month, 3 Months, and 6 months post system activation