Testing Protocol for Cold-sensing Fibers

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT05192577
• Lead Sponsor: Aalborg University

Brief Summary

This project aims to evaluate whether electrical stimulation can modulate the cold detection threshold and the cold pain threshold. The hypothesis is that different electrical stimulation will either decrease or increase the cold threshold depending on the shape of the electrical stimulus. If a combination of electrical stimuli and cold stimuli could be used, this could lead to a novel method for estimating the excitability properties of cold-sensing fibers. The sub-project takes place in 1 session (1.5 hours).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-23
• Study Start: 2021-11-24
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-14
• Primary Completion: 2023-01-30
• Study Completion: 2023-07-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy men and women
• 18-80 years
• Speak and understand English

Exclusion Criteria

• Pregnancy or breast feeding
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
• Skin diseases
• Past history of conditions possibly leading to neuropathy
• Inability to cooperate
• Current use of medications that may affect the study, e.g., analgesics
• Previous traumatic experience of an electrical accident
• Consumption of alcohol or painkillers within the last 24 hours
• Participation in other pain studies throughout the study period
• Patients with cardiac diseases (e.g., pacemaker).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Warm pain threshold with conditioning electrical stimuli	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a warm painful sensation. Simultaneous will electrical stimulation be applied.
Cold pain threshold with conditioning electrical stimuli	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a cold painful sensation. Simultaneous will electrical stimulation be applied.
The sensation of pulse 1	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The investigator will ask the participant to rate the sensation by a questionnaire. The scale will be 0-10, where 0 indicates no sensation and 10 is the worst imaginable sensation.
Cold detection threshold with conditioning electrical stimuli	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation. Simultaneous will electrical stimulation be applied.
Cold pain threshold	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a painful warm sensation.
Warm pain threshold	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a painful warm sensation.
Cold detection threshold	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation.
Perception threshold	During session 1. The estimation of the outcome measurement take approximately 15 minutes.	The Perception threshold for the cutaneous electrical stimulation will be estimated for two different pulse shapes of the electrical stimulus. The perception threshold is defined as the electrical current needed for the participant to perceive the stimulus. The perception threshold will be estimated by the method of limits.
Warm detection threshold	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation.
Warm detection threshold with conditioning electrical stimuli	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation. Simultaneous will electrical stimulation be applied.
The sensation of pulse 2	During session 1. The estimation of the outcome measurement take approximately 3 minutes.	The investigater will ask the participant to rate the sensation by a questionnaire. The scale will be from 0-10 where 0 indication no sensation and 10 the worst imaginable sensation.

Trial Locations

Locations (1)

Aalborg university; 🇩🇰 Aalborg, Nordjylland, Denmark