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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24916
Enrollment
20
Registered
2019-08-02
Start date
2019-08-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal cord injury

Interventions

None listed

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Core body temperature and skin temperature

Secondary

MeasureTime frame
Thermal sensation Pain

Contacts

Public ContactNathalie Benda

Sint Maartenskliniek

n.benda@maartenskliniek.nl024 365 94 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)