To compare an unexplained chronic fatigue group and a healthy control group on: 1) immune parameters (hs-CRP), 2) several subjective (self report) measures of non-specific symptoms of immune activity, 3) several objective measures of non-specific…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
functionele syndromen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are: blood plasma CRP-concentrations; self report of
negative mood, fatigue, pain complaints and cognitive complaints; pressure pain
parameters; and mental effort during a cognitive task.
Secondary outcome
Secondary study parameters are Indoleamine 2,3-dioxygenase-mRNA expression and
score on a pain catastrophizing questionnaire.
Background summary
The recent study is based on the assumption that medically unexplained
complaints are due to an increased sensitivity of the brain to signals from the
immune system (i.c. cytokines). The study will focus specifically on this role
of central sensitivity for cytokines in chronic unexplained fatigue. Assessment
of immune activity in chronic fatigue syndrome (CFS) has not led to consistent
findings in the past. More recent studies, however, which used a more sensitive
immunological test (high-sensitivity C-reactive protein (hs-CRP)
concentrations), did find differences between chronic fatigued and healthy
individuals. This positive development gives us the opportunity to further
study the role of immune deviations in relation to CFS complaints. This
research on non-specific symptoms of immune activity will focus on self
reported symptoms on the one hand, and more objective measures like pain
sensitivity and mental effort during tasks on the other hand.
Study objective
To compare an unexplained chronic fatigue group and a healthy control group on:
1) immune parameters (hs-CRP), 2) several subjective (self report) measures of
non-specific symptoms of immune activity, 3) several objective measures of
non-specific symptoms.
To assess dose-reponse relationships between hs-CRP and subjective and
objective non-specific symptoms within the chronic fatigue group.
Study design
An observational study with two groups: a group with unexplained chronic
fatigue and a healthy control group.
Study burden and risks
Participants are asked to travel to Utrecht on two occasions: once for the
screening appointment (1 hour), and once for the test day (3 hours).
The test day consists out of four questionnaires, one computer task and one
pain sensitivity assessment. During this day, several breaks are scheduled to
prevent the study from causing further fatigue in the chronic fatigued
participants. The questionnaires and tests used in this study have been used
before in studies with chronic fatigue participants.
During the test day, a blood sample will be obtained through vena puncture. The
vena puncture can lead to a bruise at the place of the puncture. In rare cases,
the puncture can lead to an infection at the place of the puncture.
Heidelberglaan 1
3584 CS Utrecht
Nederland
Heidelberglaan 1
3584 CS Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Female, non-smoking, age between 20 and 60 years. No medical or psychiatric disorder.
Specific for patientgroup: unexplained chronic fatigue lasting more than 6 months.
Exclusion criteria
Indication or diagnosis of any medical or psychiatric disorder. Use of systemic medication. Drugs use in month prior to study. Alcohol abuse in month prior to study. Primary sleep disorder that can account for the fatigue complaints. Pregnancy during or in three months before the study. Occurrence of an infection in the week prior to the study. Experience from earlier research shows that about 50 % of potential participants in the chronic fatigue group will be excluded due to use of systemic medication.
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 | NL30479.041.09 |