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Characterization of Secondary Hyperalgesia in Healthy Volunteers

Primary Purpose

Experimental Pain in Healthy Males

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Brief thermal sensitization
Long thermal stimulation
Heat-pain-detection threshold
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Experimental Pain in Healthy Males focused on measuring Pain, Secondary hyperalgesia, thermal sensitization, Catastrophization, Anxiety

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of anaesthesia and surgery, 4231, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experiemental pain models

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Score of Pain Catastrophizing Scale
How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?
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?
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?
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.
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.
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.

Full Information

First Posted
June 12, 2014
Last Updated
January 26, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02166164
Brief Title
Characterization of Secondary Hyperalgesia in Healthy Volunteers
Official Title
Characterization of Secondary Hyperalgesia in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Experimental Pain in Healthy Males
Keywords
Pain, Secondary hyperalgesia, thermal sensitization, Catastrophization, Anxiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiemental pain models
Arm Type
Experimental
Arm Description
all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.
Intervention Type
Other
Intervention Name(s)
Brief thermal sensitization
Other Intervention Name(s)
Experimental thermal pain model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Long thermal stimulation
Other Intervention Name(s)
Experimental pain model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Heat-pain-detection threshold
Other Intervention Name(s)
Experimental pain model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in area of secondary hyperalgesia following brief thermal sensitization
Description
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.
Time Frame
Study day 1, 2, 3, and 4. A minimum of 4 weeks.
Secondary Outcome Measure Information:
Title
Score of Pain Catastrophizing Scale
Description
How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?
Time Frame
7 days
Title
Score of Hospital Anxiety and Depression Scale
Description
How precise does the score of the Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia?
Time Frame
7 days
Title
Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale
Description
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?
Time Frame
7 days
Title
Heat-pain-detection threshold registered by degrees celsius
Description
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.
Time Frame
1 minute per session
Title
Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale
Description
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.
Time Frame
1 minute per session
Title
Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.
Description
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.
Time Frame
1 minute per session

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen B Dahl, MD, Doc. Med, Consultant
Organizational Affiliation
Department of anaesthesiology, dep. Z, Bispebjerg Hospital, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Department of anaesthesia and surgery, 4231, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27167119
Citation
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.
Results Reference
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Characterization of Secondary Hyperalgesia in Healthy Volunteers

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