Characterization of Secondary Hyperalgesia in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Experimental Pain in Healthy Males
• Intervention / Treatment: Other: Brief thermal sensitization; Other: Long thermal stimulation; Other: Heat-pain-detection threshold

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of anaesthesia and surgery, 4231, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experiemental pain models; all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.

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.; Other Names: Experimental thermal pain model; Other: 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.; Other Names: Experimental pain model; Other: 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.; Other Names: Experimental pain model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University of Copenhagen; Copenhagen Trial Unit, Center for Clinical Intervention Research
• Investigators: Study Director: Jørgen B Dahl, MD, Doc. Med, Consultant, Department of anaesthesiology, dep. Z, Bispebjerg Hospital, Denmark

Publications and helpful links

General Publications

• Hansen MS, Wetterslev J, Pipper CB, Ostervig R, Asghar MS, Dahl JB. The Area of Secondary Hyperalgesia following Heat Stimulation in Healthy Male Volunteers: Inter- and Intra-Individual Variance and Reproducibility. PLoS One. 2016 May 11;11(5):e0155284. doi: 10.1371/journal.pone.0155284. eCollection 2016. Erratum In: PLoS One. 2017 Apr 13;12 (4):e0176081.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Catastrophization; Secondary hyperalgesia; thermal sensitization
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Hyperalgesia
• Other Study ID Numbers: SM1-MSH-2014