Pain Thresholds Under High-dose Topical Capsaicin

Pain Clinical Trial

Official title: Heat-, Cold-, and Mechanical Pain Thresholds Under Exposition of High Dose Topical Capsaicin

Status Completed

Clinical Trial Summary

Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in g) immediately after to find out the exact skin temperature by which capsaicin initiates the application pain (heat pain threshold, HPT in °C) but also the temperature by which capsaicin does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the investigators want to find out the mechanical pain threshold in g from topical capsaicin and to verify a prolonged effect of capsaicin on the pain thresholds.

Clinical Trial Description

Capsaicin is the main pungent ingredient in chili peppers. Topical capsaicin 8% is used for the treatment of peripheral neuropathic pain. Application of capsaicin 8% provokes distinct pain by activating the transient receptor potential vanilloid 1 (TRPV1) receptor. Cooling the skin results in a reliable prevention of the application pain. However, the necessary cooling temperature and if cooling itself produces application pain, is unknown.

Materials and Methods: 10 female and 10 male healthy volunteers will be enrolled in a randomised, double blind, placebo controlled, cross-over study. The left or right forearm of each subject is going to be treated with a capsaicin 8% patch (QUTENZA, Astellas Pharma, Tokyo, Japan) of 9 cm² or a placebo patch (Demo patch, Astellas Pharma, Tokyo, Japan) of the same size for 60 min. Then the other forearm (which has not been tested before) will be treated with the remaining patch. During capsaicin and placebo exposure HPT in °C and CPT in °C are going to be obtained by the thermode of a thermal sensory analyser, TSA-II (Medoc Ltd., Ramat Yishai, Israel). Temperature increase/decrease of the thermode will be stopped, as soon as the subject presses a switch because of a beginning pain sensation. Immediately after exposure a pin prick test will be performed 5 times in a row by pressing a Mini-Spike (B. Braun Melsungen AG, Melsungen, Germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain (Mechanical pain threshold in g). 2 weeks later HPT, CPT, and MPT will be determined again in the areas of capsaicin and placebo exhibition. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

• NCT number: NCT02570841
• Study type: Interventional
• Source: Medical University of Vienna
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Completion date: September 2015