Peripheral Neuropathy
Conditions
Keywords
Topical treatment, Small fiber excitability, Perception Threshold Tracking Method
Brief summary
The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model. The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).
Detailed description
Design and method Study design The study is a randomized, double-blinded, placebo-controlled study. To minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. To ensure double blinding, 1-2 colleagues from Center for Neuroplasticity and Pain (CNAP), who is not otherwise involved in the project, will keep the randomization list in a secure room. Study procedure and experimental test The PTT model will be used to measure the excitability of peripheral sensory afferents. PTT will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms. In total four topical creams will be used in the study. One cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%). The study consists of one session lasting 3-4 hrs. The study will include 20 healthy volunteers.
Interventions
DRUGTopical lidocaine 5%
Drug is used to pharmacologically modulate peripheral sensory afferents
DRUGTopical Phenytoin 10%
Drug is used to pharmacologically modulate peripheral sensory afferents
DRUGTopical Mepyramine 2%
Drug is used to pharmacologically modulate peripheral sensory afferents
OTHERTopical Placebo
Drug is used as control
Sponsors
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Participant and investigator/project involved personal is blinded to which cream is applied.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men and Women age \> 18 years * Understand and speak Danish * No medication besides contraceptives
Exclusion criteria
* Pregnancy or lactating women * Drug addiction (use of cannabis, opioids, or other drugs) * Use of pain killers, alcohol, or nicotine within the last 24 hours before study start * Any other medical treatment (e.g., antidepressants, anticonvulsants) * History of peripheral or chronic pain conditions / neuropathy * Skin diseases * Scars and/or tattoos at the volar site of the forearm * Previous traumatic experience of an electrical accident * Application of moisturizing lotion of the volar site of the forearms (24 hours before study start) * Participation in any other research projects/studies 7 days before study start * Known allergy/intolerance to lidocaine/phenytoin/mepyramine * Lack of ability to cooperate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTT-value | 1 hour after application of cream | Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs. |
Countries
Denmark
Outcome results
None listed