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
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
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
NCT ID
NCT02166164
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
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
derived
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Characterization of Secondary Hyperalgesia in Healthy Volunteers
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