To investigate whether SCI patients with regular complaints of cold sensations in daily life have more impaired thermoregulatory responses to changes in environmental temperature compared to SCI patients who do not have these cold sensations in…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Between group differences in change in core body and skin temperature during
cold exposure.
Secondary outcome
Secondary study parameters are the change in core body and skin temperature
during warmer conditions.
Also, differences in baseline parameters: blood pressure, heart rate, fat
percentage, physical activity levels, life satisfaction and autonomic
functioning.
Background summary
Cold sensations are a common complaint in patients with spinal cord injury
(SCI) and have a negative effect on quality of life and daily activities.
However, the pathophysiology of these sensations and whether patients who
experience these sensations have more impaired thermoregulatory responses
compared to patients who do not, is currently unknown.
Study objective
To investigate whether SCI patients with regular complaints of cold sensations
in daily life have more impaired thermoregulatory responses to changes in
environmental temperature compared to SCI patients who do not have these cold
sensations in daily life. We hypothesize that patients with regular complaints
of cold sensations have more impaired thermoregulatory responses to changes in
environmental temperature. We expect that they are not able to stabilize their
core body temperature during changes in environmental temperature and that skin
temperature will remain stable. Moreover, we expect that patients without these
complaints in daily life will be able to keep their core body temperature
stable by varying their skin temperature (due to better vasomotor control)
under the different environmental temperatures.
Study design
This is an observational study of two SCI patient groups, one with and one
without regular complaints of cold sensations. Both groups will be exposed to a
cold environment (18-19°C) for 120 minutes and subsequently to a warmer
environment (24°C) for 60 minutes. During these interventions, core body and
skin temperature, thermal sensation, pain score, heart rate and blood pressure
will be measured.
Study burden and risks
Patients will report to the laboratory once for the measurements (4,5hr).
Beforehand, they will fill in the questionnaires (0,5hr). Cold exposure and
measuring blood pressure can cause some discomfort. For safety, body
temperature will be checked regularly and the measurements will be aborted when
temperature drops to or below 35°C or increase to or above 38.5°C. A physician
can be contacted in case of emergency. Due to the changes in physiological
processes/thermoregulation in SCI, a comparison with healthy control subjects
would not answer our research question and inclusion of a patient-control group
is necessary.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
* SCI patient of the Sint Maartenskliniek, Nijmegen
* Lesion at or above T6
* Subjects in the chronic phase of SCI (>6 months)
* Age between 18-65 years old
* Complaints of cold sensations on on at least half of the days throughout the year with a NRS of 4 or higher of limitations on activity or participation level (for half of the participants, not for the patient-control group_
Exclusion criteria
* Recent change in medication affecting (neuropathic) pain (<3 months)
* Fever on the day of measurement or the use of paracetamol the day of the measurements
* Pacemaker, implantable baclofen pump, or other implanted electrical devices
* M. Crohn, colitis ulcerosa or other gastro-intestinal disease
* Body weight < 36,5 kg
* MRI scan planned within 7 days of measurements
* Medical history of gastro-intestinal surgery
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 | NL68038.091.18 |