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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
Drug is used to pharmacologically modulate peripheral sensory afferents
Drug is used to pharmacologically modulate peripheral sensory afferents
Drug is used to pharmacologically modulate peripheral sensory afferents
Center for Neuroplasticity and Pain
Aalborg, Denmark
Change in PTT-value
Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs.
Time frame: 1 hour after application of cream
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Drug is used as control