Comparability of the OptiHair2 von Frey filaments with the Somedic Aesthesiometer 2 for the detection of tactile perception thresholds

Recruiting

• Conditions: G60-G64; Polyneuropathies and other disorders of the peripheral nervous system

• Registration Number: DRKS00024849
• Lead Sponsor: niversitätskinderklinik im St.-Josef Hospital Klinikum der Ruhr-Universität-Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Participants aged 7 years and older

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ratio between the measurement results (tactile detection thresholds) of the two sets of filaments.

Secondary Outcome Measures

Name	Time	Method
Verification that the sets are equally applicable for the determination of the individual perception threshold.