Determining the feasibility of EVNS performed at home by the patient and/or caregiver, after instruction from the podiatrist.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
i) The number and severity of reported side-effects of HOME-EVNS, gathered via
telephonic consulting on treatment day 1,3 and 8 and via user-initiated
incoming calls to the PI/SI
ii) Successful treatment defined as cycles with at least 8/10 successful (full
35 minutes) treatment sessions, derived from the adherence determined by
recording device usage and intensity setting which is downloaded from device
after its retrievalof having at least 8/10 adequate treatment sessions
iii) Usability, determined by the USER-Experience questionnaire (UEQ), and
iv) Number of help requests to service desk
Secondary outcome
i) Neuropathic Pain Symptom Inventory (NPSI)
ii) EQ-5D-5L, Quality of Life score
Background summary
Painful diabetic peripheral neuropathy (PDPN) affects a significant percentage
of patients with diabetes mellitus in Europe and even more so in Africa and the
Middle East. Various international, European, and North American guidelines
recommend tricyclic agents (TCA), serotonin-norepinephrine reuptake inhibitors
(SNRIs), and gamma-aminobutyric acid (GABA) analogues as first and second line
treatments for PDPN, but there is no consensus on the use of morphine or
tramadol. However, up to 75% of patients with PDPN do not respond to these
treatments and require more advanced therapies to relieve pain. The economic
burden of PDPN is also significant. Specific forms of electrical stimulation
(such as FREMS, a kind of electrical vasomotor nerve stmulation that use
sequences of modulated electrical stimuli), has shown promise in reducing pain
in patients with PDPN in randomized controlled trials. In a phase IV study the
treatment proved effective and reduced medication use significantly. However,
the treatment was given in an out patient setting, not favourable for the
usually less mobile subjects. Therefore the current study is conducted using
specific electrostimulation (EVNS) in the home setting.
Study objective
Determining the feasibility of EVNS performed at home by the patient and/or
caregiver, after instruction from the podiatrist.
Study design
Intervention study
Intervention
The treatment with electrostimulation via EVNS is performed using the Releaf
device (Neurecon, Vught, Netherlands). The technique utilizes four independent
channels per leg, each with two pairs of electrodes. During the instruction,
the optimal intensity for neurostimulation is set for each pair of electrodes
by gradually increasing it until the patient perceives the sensation as intense
but not painful. In the home setting, the patient can use and adjust this
setting. This treatment is applied for 35 minutes per day for 10 consecutive
days.
Study burden and risks
The specific time that participants spend on the treatment is 10 times 60
minutes over 10 consecutive days. Prior to this, an instruction session takes
place with their own podiatrist; the rest of the treatment involves efforts in
the home environment. The application is designed to be feasible in the home
setting after the instruction. The entire procedure includes setting up the
device and applying electrodes (15 minutes), the treatment itself (35 minutes),
and disconnecting, cleaning up, and dressing (10 minutes).
The feasibility of the treatment and its effects will be assessed through the
completion of seven questionnaires. The estimated time commitment per
questionnaire (pre-treatment, after 1 month, and after 3 months) is expected to
be a maximum of 20 minutes. Therefore, the total time commitment is estimated
to be 660 minutes for the entire study.
No anticipated psychological discomfort is apparent. There is a helpdesk
available for any questions or issues.
No side effects have been reported previously from the electrostimulation.
Isabellastraat 9
Vught 5261 AG
AF
Isabellastraat 9
Vught 5261 AG
AF
Listed location countries
Age
Inclusion criteria
Painful Diabetic Neuropathy refractory for at least 2 pharmacological
interventions
Being in a mentall and physical state to perform home self-treatment with
Releaf for 10 consecutive days or with adequate assistance of care-giver
Being in a mental and physical state to understand and complete the research
questionnaires
Exclusion criteria
In case of other evident causes for painful neuropathy, significant peripheral
arterial disease,
active foot ulceration, current alcohol or other substance abuse (use of
alcohol over the recommended limits of less than 21 units of alcohol per week
in men and 14 units in
women, presence of a medical device based on electrical stimulation, cardiac
pacemaker and/or implantable cardioverter defibrillator or any other active
implant*
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84421.000.23 |