Experimental Pain in Healthy Males
Conditions
Keywords
Pain, Secondary hyperalgesia, thermal sensitization, Catastrophization, Anxiety
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.
Interventions
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.
OTHERLong 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.
OTHERHeat-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.
Sponsors
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in area of secondary hyperalgesia following brief thermal sensitization | Study day 1, 2, 3, and 4. A minimum of 4 weeks. | 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
| Measure | Time frame | Description |
|---|---|---|
| Score of Hospital Anxiety and Depression Scale | 7 days | 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 | 7 days | 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? |
| Score of Pain Catastrophizing Scale | 7 days | How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia? |
| Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale | 1 minute per session | 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. | 1 minute per session | 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. |
| Heat-pain-detection threshold registered by degrees celsius | 1 minute per session | 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. |
Countries
Denmark
Outcome results
None listed