Functioning of the HPA-axis in patients with Complex Regional Pain Syndrome

Functioning of the HPA-axis in patients with Complex Regional Pain Syndrome - CRPS HPA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52914

Enrollment

120

Registered

2020-09-25

Start date

2021-05-07

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Complex regional pain syndrome posttraumatic dystrophy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Patients with CRPS: - Age

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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	—

Measure

Time frame

- 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

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Countries

Netherlands

Outcome results