Characterization of Secondary Hyperalgesia in Healthy Volunteers

Experimental Pain in Healthy Males Clinical Trial

Official title:

Characterization of Secondary Hyperalgesia in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166164
• Other study ID #: SM1-MSH-2014
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: January 26, 2015
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish ethics committeeDenmark: Danish Data Protection Agency
• Study type: Interventional

Clinical Trial Summary

In this prospective trial we aim to investigate the intra-individual and inter-individual variance in secondary hyperalgesia following pain elicited by the experimental pain model: Brief Thermal Sensitization.

Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age >18 years and <35 years

• Speak and understand Danish

• Male gender

• Test subjects who have understood and signed the informed consent

• No prescription medicine during the last 30 days

Exclusion Criteria:

• Test subjects that cannot cooperate to the test

• Test subjects with an alcohol and/or substance abuse, assessed by the investigator

• Test subjects, who have consumed one or several types of analgesics 2 <days before the study

• Test subjects, who have consumed antidepressant medication during the last 30 days before the study

• Test subjects with chronic pain

• Test subjects with psychiatric diagnoses

• Test subjects with tattoos on the extremities

• Body Mass Index of >30 or <18

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Experimental Pain in Healthy Males
• Hyperalgesia

Intervention

Other:
• Brief thermal sensitization
A small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.
• Long thermal stimulation
A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.
• Heat-pain-detection threshold
The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered. 4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.

Locations

Country	Name	City	State
Denmark	Department of anaesthesia and surgery, 4231, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in area of secondary hyperalgesia following brief thermal sensitization	To determine the intra- and inter-individual variance, and the inter- and intra-observer variance of the secondary hyperalgesia areas following brief thermal sensitization on 4 separate experimental days with two different observers.	Study day 1, 2, 3, and 4. A minimum of 4 weeks.	No
Secondary	Score of Pain Catastrophizing Scale	How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?	7 days	No
Secondary	Score of Hospital Anxiety and Depression Scale	How precise does the score of the Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia?	7 days	No
Secondary	Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale	How precise do the subscales in the two psychological tests (PCS-rumination, PCS-magnification, PCS-helplessness, and HADS-Anxiety, HADS-Depression) predict the size of the area of secondary hyperalgesia?	7 days	No
Secondary	Heat-pain-detection threshold registered by degrees celsius	How precise do the Heat-pain-detection threshold evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Heat-pain-detection threshold on 4 separate experimental days with 1 session per experimental day.	1 minute per session	No
Secondary	Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale	How precise does the Max. VAS-score following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per experimental day.	1 minute per session	No
Secondary	Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.	How precise does the VAS-Area Under the Curve following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per study day.	1 minute per session	No