Objective of the study: With this pilot study we attempt to explore the possibility to treat patients suffering from intractable neuropathic pain with CVS
ID
Source
Brief title
Condition
- Other condition
- Mental impairment disorders
Synonym
Health condition
centrale pijnklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/outcome of the study: Changes in NRS pain scores as a
result of the CVS treatment
Secondary outcome
Secundary study parameters/outcome of the study: Immediately following and a
week after CVS treatment patients will be asked about the experiences, both
positive and negative, they attribute to the CVS treatment
Background summary
Background of the study: Central pain is caused by a dysfunction of the brain
and/or the spinal cord. The exact mechanism is unclear but usually there is an
incongruence between anticipated and actual somatosensory input. Treatment of
these patients is very complicated. Due to the widespread *neuropathic* pain
complaints combined with a treatment resistancy, this will lead to pain
*suffering* in both patients as well as relatives.
Recently, a non-invasive approach called caloric vestibular stimulation (CVS)
has been described and evaluated in these patients. CVS directly activates a
complex network of areas predominantly in the temporo-insular and
temporo-parietal cortex of both hemispheres. The activated areas receive
multisensory information (vestibular, visual, proprioceptive, tactile) and are
thought to be involved in body ownership and embodiment.
The effects of CVS on pain appear to be dramatic with a long lasting effect in
a number of patients. Studying the effects of this approach might lead to a new
way of treating these patients and these pain syndromes.
Study design: Pain scores of patients will be obtained before, immediately
following and a week after a single CVS treatment.
Study population: For this pilot, six adult patients with treatment-resistant
central neuropathic pain in the upper body on the non-dominant side will be
recruited in the Pain Center of UMC St Radboud. Patients will have to provide
written informed consent. Excluded from this pilot study are patients with the
following conditions: Other neurological disorders causing pain, significant
cardiac or respiratory disease (inadequately treated hypertension), ear disease
such as a perforated ear drum or otitis media/externa, vestibular disease or
significant motion sickness, or pregnancy.
Study objective
Objective of the study: With this pilot study we attempt to explore the
possibility to treat patients suffering from intractable neuropathic pain with
CVS
Study design
Study design: Pain scores of patients will be obtained before, immediately
following and a week after a single CVS treatment.
Study population: For this pilot, six adult patients with treatment-resistant
central neuropathic pain in the upper body on the non-dominant side will be
recruited in the Pain Center of UMC St Radboud. Patients will have to provide
written informed consent. Excluded from this pilot study are patients with the
following conditions: Other neurological disorders causing pain, significant
cardiac or respiratory disease (inadequately treated hypertension), ear disease
such as a perforated ear drum or otitis media/externa, vestibular disease or
significant motion sickness, or pregnancy.
Intervention
Intervention: The patient will be positioned in a supine position with head at
a 30° elevated angle. Patients will receive ear canal irrigation with ice water
(~4°C) on the dominant side (right ear for right handed people). The
irrigation (~30 ml) will continue until there are demonstrable signs of
nystagmus and reports of vertigo, but at least 30 s.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: CVS with ice water is a safe technique that is
normally used for diagnostic purposes. The strong stimulation may acutely
result in a transient dizziness and nausea. The anticipated benefit is a much
longer lasting relieve of the neuropathic pain. The cold temperature of the
fluid might be uncomfortable.
Geert Grooteplein zuid 10
6500 HB Nijmegen
Nederland
Geert Grooteplein zuid 10
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
• Neuropathic pain in the non-dominant side
• Resistant to or not suitable for other treatments
Exclusion criteria
• Other neurological disorders causing pain.
• Significant cardiac or respiratory disease (inadequately treated hypertension)
• Ear disease such as a perforated ear drum or otitis media/externa
• Vestibular disease or significant motion sickness
• Pregnancy
Design
Recruitment
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 | NL31513.091.10 |