Healthy Volunteers Are Studied
Conditions
Keywords
burn injury, cold pressor test, gender, pain, pain sensitivity, pain prediction, psychometrics, quantitative sensory testing
Brief summary
Pain is a complex experience influenced by gender and genetics, and, by psychosocial and sensory experiences. Pain sensitivity is thus highly variable between individuals. In the present study we evaluate individuals´ pain perception in response to a number of different pain stimuli in 100 healthy volunteers (50 females and 50 males). The data will allow us to assess pain sensitivity, to predict pain responses and to investigate gender related differences in pain perception. A second aim is to evaluate the robustness of the different pain-tests since the tests are repeated with an interval of 2-4 weeks.
Detailed description
Pain perception is affected by physiological, psychological, existential and demographic factors. In the present study psychophysiological, psychological, genetic and demographic components in pain perception are evaluated in healthy volunteers (n = 100). Psychophysical assessments following induction of a first degree burn injury (47.0 C, 420 s, 12.5 sq.cm, lower leg) include: * pain during induction of burn injury * thermal thresholds * tactile thresholds * electrical thresholds * areas of secondary hyperalgesia * pressure algometric assessments * assessment of Diffuse Noxious Inhibitory Control (DNIC) efficiency * assessment of (DNIC) using cold pressor test Psychological assessments include: * HADS (Hospital Anxiety and Depression Scale) * PCS (Pain Catastrophizing Scale) * vulnerability score Genetics include: \- A118G SNP Demographics include: * gender * height * weight
Interventions
PROCEDUREfirst degree cutaneous burn injury
application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
Sponsors
Norpharma A/S
University of Copenhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy * psychomotor ability to perform the tests * cognitive ability to perform the tests
Exclusion criteria
* smoker * Body Mass Index \> 28 * participation in drug studies \< 4 weeks prior to inclusion * chronic pain * chronic intake of analgesics * drug or alcohol abuse * intake of analgesics \< 48 hours prior to study * females not on contraceptive therapy (intra-uterine device or p-pill) * lesion in the assessment area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain following burn injury | from baseline to 420 s after burn injury |
Secondary
| Measure | Time frame |
|---|---|
| tactile thresholds | followed for 180 min after burn injury |
| pressure algometry assessments | 95 min prior to burn injury |
| DNIC-efficiency | 45 min before burn injury |
| thermal thresholds | followed for 180 min after burn injury |
| HADS score | 2 hours before the burn injury |
| PCS ratings | 2 hours before the burn injury |
| A118G SNP | 8 months after inclusion completed |
| cold pressor test | 85 min before burn injury |
Countries
Denmark
Outcome results
None listed