Thermoregulation in patients with spinal cord injury and cold sensations, an explorative pilot-study

• Conditions: Spinal cord injury

• Registration Number: NL-OMON24916
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

•Patient of the Sint Maartenskliniek, Nijmegen
•Lesion at or above T6
•Subjects are 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 or limitations on activity or participation level (in 50% of the study population, not in 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, (suspection of) obstructive disease of the gatro-intestinal tract or other gastro-intestinal disease
•Patients with hypomotility disorders of the gastro-intestinal tract (we define this as severe obstipation)
•(History of) impairment of gag reflex
•Felinization esophagus
•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
Core body temperature and skin temperature

Secondary Outcome Measures

Name	Time	Method
Thermal sensation<br>Pain<br>