To determine if SCS and/or DRGS is can influence the perception of experimentally induced pruritus.
ID
Source
Brief title
Condition
- Other condition
- Peripheral neuropathies
Synonym
Health condition
experimentele pruritus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Itch intensity will be recorded using a visual analog scale (VAS). Patients*
VAS score will be noted at baseline, after switching off of the
neurostimulator, 15 minutes after application of histamine, and 1, 5, 10, 15
and 30 minutes after the stimulator has been switched on. All measurements will
be noted for both sides, separately.
Secondary outcome
The size of the flare will be measured at all timepoints after application of
histamine. At all timepoints after histamine application, character and
variance of itch perception will be determined, by means of a questionnaire.
All measurements will be noted for both sides, separately.
Background summary
Electrical neuromodulation therapies such as transcutaneous electrical nerve
stimulation (TENS), spinal cord stimulation (SCS) and dorsal root ganglion
stimulation (DRGS) have earned their place in the treatment of neuropathic pain
and are commonly used as a last resort treatment for neuropathic pain. Though
it is known that pain and pruritus are neurologically related phenomena,
electrical neuromodulation is far less used in the treatment of itch. None the
less, there is evidence that modes of electrical neuromodulation such as TENS
are useful in the treatment of pruritus. To our knowledge, there are no papers
published on the effects of SCS and DRGS on the occurrence and intensity of
itch. We hypothesize that these modes of neuromodulation are effective forms of
treatment for itch.
Study objective
To determine if SCS and/or DRGS is can influence the perception of
experimentally induced pruritus.
Study design
This is an experimental pilot-study. We will enroll 12 patients, ideally 6 with
an SCS-device and 6 with a DRGS-device. These patients will be carefully
selected to meet the following criteria: No pre-existent skin disease, no
sensibility disorder, no known allergies or hypersensitivities, availability of
an unaffected area in a dermatome corresponding to the location of their
device, good responder to their neuromodulation therapy.
Intervention
After switching off the SCS or DRGS, histamine will be applied percutaneously
to a healthy area of skin innervated by the neurostimulator, as well as to a
healthy area of skin not innervated by the neurostimulator. The resulting itch
will be recorded, after which the SCS or DRGS will be switch on again.
Subsequently, itch intensity will be measured again after 1, 5, 10, 15 and 30
minutes of stimulation.
Study burden and risks
Participants might temporarily experience an increase in pain, after switching
off the SCS or DRGS. Maximum duration hereof is approximately 30 minutes, after
which the SCS or DRGS will be turned on again. Due to the nature of the study,
participants will temporarily experience localized itch and they will develop
two flares, comparable to mosquito bites. Both the itch and the flares will
vanish spontaneously within one to two hours, as well as within several minutes
after application of a corticosteroid containing dermal cream. The risk of
serious or permanent harm or serious adverse events is negligible. Switching on
and off the neurostimulator is a well-known and routine act to patients.
There is no benefit in participation, other than aiding the advance of science.
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Good effect (>= 50% decrease of pain) of spinal cord stimulation (SCS) or
dorsal root ganglion stimulation (DRGS) treatment.
- The area innervated by the SCS or DRGS must extend to a healthy, pain-free,
uninterrupted area of skin of at least 10x20cm
- Contralaterally, an equal, uninterrupted, healthy area of skin must be
available; this must not be innervated by the stimulator.
- Patient must have no objections against switching off his or her device, for
up to one hour.
- Age >=18 years
- No ongoing itch perception
Exclusion criteria
- Generalized skin disorder,
- Systemic disease associated with pruritus,
- Complex regional pain syndrome
- Allergy or hypersensitivity
- Contra-indication for histamine administration, such as mastocytosis
- Use of opioids
- Use of oral antihistamines, corticosteroids or other (immunosuppressive)
drugs that might prevent potential participants from developing a flare.
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 | NL73015.078.20 |