Healthy Volunteers Are Studied Clinical Trial
— PASORIOfficial title:
Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | February 2011 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 40 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9 | Copenhagen O |
| Lead Sponsor | Collaborator |
|---|---|
| University of Copenhagen | Norpharma A/S |
Denmark,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pain following burn injury | from baseline to 420 s after burn injury | No | |
| Secondary | thermal thresholds | followed for 180 min after burn injury | No | |
| Secondary | tactile thresholds | followed for 180 min after burn injury | No | |
| Secondary | pressure algometry assessments | 95 min prior to burn injury | No | |
| Secondary | DNIC-efficiency | 45 min before burn injury | No | |
| Secondary | cold pressor test | 85 min before burn injury | No | |
| Secondary | HADS score | 2 hours before the burn injury | No | |
| Secondary | PCS ratings | 2 hours before the burn injury | No | |
| Secondary | A118G SNP | 8 months after inclusion completed | No |