An interventional study of Brief thermal sensitization and Long thermal stimulation in Experimental Pain in Healthy Males, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-27.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Basic science
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.
152 studies on the registry are indexed under Hyperalgesia; 13 are open to participants now.
This study's planned enrollment of 50 is above the median of 42 across 127 interventional studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
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 · Other: Long thermal stimulation · Other: Heat-pain-detection threshold
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.
Also known as: Experimental thermal pain model
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.
Also known as: Experimental pain model
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.
Also known as: Experimental pain model
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.
Time frame: Study day 1, 2, 3, and 4. A minimum of 4 weeks.
Score of Pain Catastrophizing Scale
How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?
Time frame: 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?
Time frame: 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?
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 minute per session
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark