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Functioning of the HPA-axis in patients with Complex Regional Pain Syndrome. An observational study

Functioning of the HPA-axis in patients with Complex Regional Pain Syndrome. An observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28587
Enrollment
120
Registered
2020-11-26
Start date
2020-12-09
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

Complex Regional Pain Syndrome Carpal Tunnel Syndrome

Interventions

None listed

Sponsors

Center for Pain Medicine Department of Anesthesiology Erasmus MC University Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients with CRPS: - Age = 18 years - Diagnosis of CRPS according to the new IASP (International Association for the Study of Pain) criteria for diagnosis of CRPS - One upper extremity is affected Patients with CTS - Age = 18 years - Diagnosis of CTS confirmed with electromyography

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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 outcomes

Primary

MeasureTime frame
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) •Hair cortisol

Secondary

MeasureTime frame
• Cortisol binding globulin • Level of soluble IL2-receptor in blood • Biomarkers; sCD163 and sCD206 • 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. • General parameters for all participants: gender, age, medical history, medication use, allergies, weight (kg), length (cm), side of affected limb, date of diagnosis, smoking, use of alcohol, drugs and/or anabolic/androgenic steroids, and socioeconomic status (using level of education as indicator). • Additional parameters for CRPS patients: - CRPS severity score - Presence of neuromodulation; if present also specification of type of neuromodulation

Contacts

Public ContactCorinne van den Berg

Erasmus MC

c.vandenberg.6@erasmusmc.nl06-21000458

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)