A Mechanistic Evaluation of the Interactions Between Thermoceptive and Pruriceptive Sensory Processing

Not Applicable

Completed

• Conditions: Thermal Stimulation; Cowhage; Serotonine; Itch; Histamine
• Interventions: Other: Histamine; Drug: Lidocaine; Other: Cowhage; Other: Heat stimulation; Other: Pre-heating; Other: Serotonin

• Registration Number: NCT03576053
• Lead Sponsor: Aalborg University

Brief Summary

The purpose of this human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. Moreover, the purpose is to evaluate the effect of mild pre-heating of the skin in human experimental models of histamine, cowhage and serotonin. Finally, we want to investigate the effect of short-term intense heat stimulation on previously anesthetized skin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-06-22
• Study Start: 2018-07-01
• Study First Posted: 2018-07-03
• Primary Completion: 2019-07-31
• Study Completion: 2019-08-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Healthy men and women
• Age 18-60 years
• Able to speak and understand English

Exclusion Criteria

• Suffering from chronic disease
• Pregnancy or lactation
• Prior experience of adverse effects from anaesthetic, specifically Lidocaine
• Drug addiction defined as the use of cannabis, opioids or other drugs - 5 -
• Previous neurologic, musculoskeletal or mental illnesses
• Lack of ability to cooperate
• Current use of medications that may affect the trial
• Active skin diseases
• Active participation in other experiments currently ongoing or within the last 14 days
• Tattoos on volar forearms that will interfere with local skin measurements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Histamine+cowhage+heat	Heat stimulation	-
lidocaine and saline+heat	Heat stimulation	-
Histamine+cowhage+heat	Histamine	-
Histamine+cowhage+serotonin+pre-heating	Histamine	-
Histamine+cowhage+serotonin+pre-heating	Pre-heating	-
Histamine+cowhage+heat	Cowhage	-
Histamine+cowhage+serotonin+pre-heating	Cowhage	-
Histamine+cowhage+serotonin+pre-heating	Serotonin	-
lidocaine and saline+heat	Lidocaine	-

Primary Outcome Measures

Name	Time	Method
eVAS Itch	10 minutes	Electronic Visual Analog Scale for itch sensation. 0-100 scale, it measures the self-estimated itch the subject experience on a scale where 0 correspond to "No itch" and 100 "Worst itch imaginable".
eVAS Pain	10 minutes	Electronic Visual Analog Scale for pain sensation. 0-100 scale, it measures the self-estimated pain the subject experience on a scale where 0 correspond to "No pain" and 100 "Worst pain imaginable".
Skin temperature	5 seconds	Infrared skin thermometer

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Nordjylland, Denmark