Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2010-02-28
2011-02-28
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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gender
first degree cutaneous burn injury
application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
Interventions
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first degree cutaneous burn injury
application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* psychomotor ability to perform the tests
* cognitive ability to perform the tests
Exclusion Criteria
* 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
20 Years
40 Years
ALL
Yes
Sponsors
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Norpharma A/S
INDUSTRY
University of Copenhagen
OTHER
Responsible Party
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mads u werner
MD, DMSci
Principal Investigators
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Mads U Werner, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark
Locations
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Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9
Copenhagen O, , Denmark
Countries
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References
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Luginbuhl M, Schnider TW, Petersen-Felix S, Arendt-Nielsen L, Zbinden AM. Comparison of five experimental pain tests to measure analgesic effects of alfentanil. Anesthesiology. 2001 Jul;95(1):22-9. doi: 10.1097/00000542-200107000-00009.
Edwards RR, Fillingim RB, Ness TJ. Age-related differences in endogenous pain modulation: a comparison of diffuse noxious inhibitory controls in healthy older and younger adults. Pain. 2003 Jan;101(1-2):155-65. doi: 10.1016/s0304-3959(02)00324-x.
Neziri AY, Scaramozzino P, Andersen OK, Dickenson AH, Arendt-Nielsen L, Curatolo M. Reference values of mechanical and thermal pain tests in a pain-free population. Eur J Pain. 2011 Apr;15(4):376-83. doi: 10.1016/j.ejpain.2010.08.011. Epub 2010 Oct 6.
Neziri AY, Curatolo M, Nuesch E, Scaramozzino P, Andersen OK, Arendt-Nielsen L, Juni P. Factor analysis of responses to thermal, electrical, and mechanical painful stimuli supports the importance of multi-modal pain assessment. Pain. 2011 May;152(5):1146-1155. doi: 10.1016/j.pain.2011.01.047. Epub 2011 Mar 10.
Ravn P, Frederiksen R, Skovsen AP, Christrup LL, Werner MU. Prediction of pain sensitivity in healthy volunteers. J Pain Res. 2012;5:313-26. doi: 10.2147/JPR.S33925. Epub 2012 Aug 29.
Other Identifiers
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H-1-2009-132
Identifier Type: -
Identifier Source: org_study_id