Thermoregulation in patients with spinal cord injury and cold sensations, an explorative pilot-study
- Conditions
- palsyparalysisparaplegiaspinal cord injurytetraplegia10041543
- Registration Number
- NL-OMON45840
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* 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_
* 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Between group differences in change in core body and skin temperature during<br /><br>cold exposure. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are the change in core body and skin temperature<br /><br>during warmer conditions.<br /><br>Also, differences in baseline parameters: blood pressure, heart rate, fat<br /><br>percentage, physical activity levels, life satisfaction and autonomic<br /><br>functioning.</p><br>