G60-G64
Conditions
Interventions
Group 1: Comparison of OptiHair2 set with Aesthesiometer 2 in patients with polyneuropathy
Group 2: Comparison of OptiHair2 set with Aesthesiometer 2 in healthy volunteers (control group)
Sponsors
Universitätskinderklinik im St.-Josef Hospital Klinikum der Ruhr-Universität-Bochum
Eligibility
Sex/Gender
All
Age
7 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged 7 years and older
Exclusion criteria
Exclusion criteria: Healthy individuals: -age under 7 years -Missing informed consent -Average pain intensity in the last 4 weeks > 2 (NRS 0-10) -current pain intensity > 0 (NRS 0-10) -insufficient knowledge of German or other communication problems -treatment with topical local anesthetics in the last 6 weeks -Treatment with topical capsaicin in the last 6 months -Epilepsy treated with anticonvulsants (carbamazepine, gabapentin, oxcarbazepine, pregabalin, valproate, etc.) -psychiatric disorder (e.g., major depression, bipolar disorder, anxiety disorder) treated with antidepressants with proven effect on neuropathic pain (tricyclic AD, e.g., amitriptyline; SNRI, e.g., duloxetine, venlafaxine; SSRI, e.g., citalopram) -psychiatric illness (e.g., major depression, bipolar disorder, anxiety disorder) treated with anticonvulsants -Other severe systemic or focal CNS affection (e.g., stroke, spinal cord lesion, syringomyelia) -Other central or peripheral neurologic disease (e.g., Parkinson's disease, polyneuropathy, multiple sclerosis, dementia, neuropathies, radiculopathies or nerve lesions, migraine) -peripheral arterial occlusive disease (except for stage Fontaine I) -severe cognitive or psychiatric impairment -severe internal diseases -diabetes mellitus, hypothyroidism -Substance abuse Neuropathy patients: -age < 18 -lack of informed consent -insufficient knowledge of German or other communication problems -treatment with topical local anesthetics in the last 6 weeks -treatment with topical capsaicin in the last 6 months -psychiatric illness (e.g., major depression, bipolar disorder, anxiety disorder) treated with antidepressants with proven effect on neuropathic pain (tricyclic AD, e.g., amitriptyline; -SNRI, e.g., duloxetine, venlafaxine; SSRI, e.g., citalopram) -psychiatric illness (e.g., major depression, bipolar disorder, anxiety disorder) treated with anticonvulsants -Other severe systemic or focal CNS affection (e.g., stroke, spinal cord lesion, syringomyelia) -Other central or peripheral neurologic disease (e.g., Parkinson's disease, multiple sclerosis, dementia, radiculopathies or nerve lesions, migraine) -other pain disorders (e.g., joint diseases, musculo-tendinous diseases, fractures, chronic wounds) -peripheral arterial occlusive disease (except for stage Fontaine I) -severe cognitive or psychiatric impairment -severe internal diseases -substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio between the measurement results (tactile detection thresholds) of the two sets of filaments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Verification that the sets are equally applicable for the determination of the individual perception threshold. | — |
Countries
Germany
Contacts
Public ContactLynn Eitner
Universitätskinderklinik im St. Josef-HospitalKlinikum der Ruhr-Universität-Bochum
Outcome results
None listed