1. To explore the complex relation between CRPS, functioning of the HPA-axis and inflammatory activation of the immune system.2. To assess associations between the HPA-axis and psychosocial determinants. 3. To explore the possible role of…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is functioning of the HPA-axis. For optimal
examination of functioning of the HPA axis various measurements of cortisol
levels will be used.
- Cortisol awakening response (CAR)
- Dexamethasone suppression test (DST) with administration of 0.25 mg
dexamethasone
- Hair cortisol
Secondary outcome
- General parameters for all participants:
Gender, age, medical history, medication use, weight (kg), length (cm),
smoking, side of affected limb, date of diagnosis, socioeconomic status (three
indices; level of education, income, occupation).
- Psychosocial determinants:
Questionnaires focusing on the severity of the pain, awareness of disease and
perception, perceived health and quality of life, coping, anxiety and
depression will be used.
- Cognition:
A neuropsychology test battery of ten cognitive tests will be used.
- Cortisol binding globulin (CBG)
CBG is the major transport protein for cortisol within the blood and about 75%
of circulating cortisol is bound to CBG. The active fraction of plasma cortisol
will thus depend on the concentration of CBG.
- Level of soluble IL2-receptor (sIL-2R) in blood;
sIL-2R levels reflect the level of T-cell activation.
- Biomarkers; sCD163 and sCD206
The soluble forms of CD206 and CD163 are suggested as biomarkers of macrophage
activity and thereby inflammatory activation. Moreover, sCD163 and sCD206 serum
levels are hypothesized to be indicative of in vivo corticosteroid resistance.
Both sCD163 and sCD206 will be measured in plasma using ELISA (enzyme-linked
immunosorbent assay)
Additional parameters for CRPS patients:
- CRPS severity score.
- Presence of neuromodulation; if presence also specification of type of
neuromodulation
Background summary
The exact pathophysiologic mechanism of Complex Regional Pain Syndrome (CRPS)
is still unknown, but there is considerable evidence for the role of
inflammation. Increased inflammatory activity can be related to dysfunction of
the hypothalamic-pituitary-adrenal-axis (HPA axis). Dysfunction of the HPA-axis
may be associated with the initiation and maintenance of inflammation in CRPS.
However, the role of the HPA-axis in CRPS is still largely unexplored. To
better understand and treat CRPS it is essential to understand the functioning
of the HPA-axis in CRPS. Possible associations with psychosocial determinants,
cognitive function and glucocorticoid sensitivity will also be investigated.
Study objective
1. To explore the complex relation between CRPS, functioning of the HPA-axis
and inflammatory activation of the immune system.
2. To assess associations between the HPA-axis and psychosocial determinants.
3. To explore the possible role of glucocorticoid sensitivity in patients with
CRPS.
4. To compare functioning of the HPA-axis between patients diagnosed with CRPS
and patients with carpal tunnel syndrome, a different cause of neuropathic
pain. Both will be compared with each other and with known normal values of
healthy persons.
Study design
Observational study
Study burden and risks
The study is conducted during two visits at the outpatient clinic of the Center
for Pain Medicine. Cortisol levels are measured and a dexamethasone suppression
test is performed using 0.25mg dexamethasone. Multiple questionnaires will be
used to obtain information about psychosocial determinants and during first
visit also physical examination and cognitive tests will take place. This study
carries a negligible risk related to venepuncture as well as a small risk of
emotional disturbance related to the content of the questionnaires. To reduce
patient burden, the questionnaires are split into two parts. The risk of the
overnight dexamethasone suppression test is negligible due to using lowest
possible dosage, only 0.25mg. There is no direct benefit for participants, nor
does this study influence or change the treatment of a patient.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Patients with CRPS:
- Age >= 18 years
- Diagnosis of CRPS according to the new IASP criteria for diagnosis of CRPS
- One extremity (upper or lower) is affected
- Signed informed consent
Patients with CTS
- Age >= 18 years
- Diagnosis of CTS: clear clinical presentation where no additional
investigation was necessary or confirmed with electromyography or median nerve
ultrasound.
- Signed informed consent
Exclusion criteria
Patients with CRPS:
- Age < 18 years
- More than one extremity affected
- History of auto-inflammatory or autoimmune disease
- Current treatment with glucocorticoids or treatment within the last 6 months.
- Current treatment with immune-modulating medicines, like bisphosphonates, or
treatment within the last 6 months.
- Suspected or confirmed pregnancy.
- Dementia
- Insufficient understanding of the Dutch language
- Allergy to dexamethasone
Patients with CTS
- Undergone CTS treatment
- (Consideration of) diagnosis of CRPS in history
- Age < 18 years
- History of auto-inflammatory or autoimmune disease
- Current treatment with glucocorticoids or treatment within the last 6 months.
- Current treatment with immune-modulating medicines, like bisphosphonates, or
treatment within the last 6 months.
- Suspected or confirmed pregnancy.
- Dementia
- Insufficient understanding of the Dutch language
- Allergy to dexamethasone
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 | NL74004.078.20 |