E75.2
Conditions
Interventions
Group 1: This is an observational study involving patients with Fabry disease who are receiving care at the FAZiT Fabry Center of the University Hospital Würzburg. Patients will be informed about the
General Depression Scale) will be completed. In addition, blood samples for study analyses will be collected and, in patients treated with Qutenza®, an additional skin biopsy will be obtained if the t
Sponsors
Universitätsklinikum Würzburg - Fabry-Zentrum (FAZiT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: For participation in the therapeutic observational part of the study, patients must report a pain intensity of =4, both verbally and in the Würzburg Fabry Pain Questionnaire, either at the time of assessment or during the previous 4 weeks. This level of pain must be present for more than 10% of the time, or patients must report a subjective need for analgesic treatment. In addition, during a routine clinical visit, patients must have chosen treatment with either a topical capsaicin patch (Qutenza®) or palmitoylethanolamide (PEA) from the available analgesic treatment options offered according to the current guideline for neuropathic pain and the current evidence. All participants must be at least 18 years of age at the time of study enrollment.
Exclusion criteria
Exclusion criteria: Insufficient proficiency in the German language or inability to provide informed consent independently. For the treatment part: absence of pain, no subjective burden caused by pain, or contraindication to either treatment. For the skin biopsy: anticoagulant therapy or other coagulation disorders, pronounced ankle edema, or inflammatory or trophic skin changes at the biopsy site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity and pain frequency, assessed using the Würzburg Fabry Pain Questionnaire before initiation of treatment and at routine follow-up visits during the 3-month observational period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in intraepidermal nerve fiber density (IENFD) and in the ratio of cold-sensitive to heat-sensitive nerve fibers in skin biopsies before and after treatment with Qutenza®; change in small nerve fiber function assessed by quantitative sensory testing (QST); change in systemic pro-inflammatory cytokine levels in blood samples after 3 months of treatment with palmitoylethanolamide (PEA); assessment of the Neuropathic Pain Symptom Inventory (NPSI) and the Allgemeine Depressionsskala (ADS; General Depression Scale) at routine follow-up visits. | — |
Countries
Germany
Contacts
Public ContactClaudia Sommer
Universitätsklinikum Würzburg
Outcome results
None listed