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Clinical Trials/NCT01345877
NCT01345877
Completed
Not Applicable

Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests

University of Copenhagen1 site in 1 country100 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Volunteers Are Studied
Sponsor
University of Copenhagen
Enrollment
100
Locations
1
Primary Endpoint
pain following burn injury
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
February 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mads u werner

MD, DMSci

University of Copenhagen

Eligibility Criteria

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

Outcomes

Primary Outcomes

pain following burn injury

Time Frame: from baseline to 420 s after burn injury

Secondary Outcomes

  • pressure algometry assessments(95 min prior to burn injury)
  • thermal thresholds(followed for 180 min after burn injury)
  • DNIC-efficiency(45 min before burn injury)
  • A118G SNP(8 months after inclusion completed)
  • tactile thresholds(followed for 180 min after burn injury)
  • cold pressor test(85 min before burn injury)
  • HADS score(2 hours before the burn injury)
  • PCS ratings(2 hours before the burn injury)

Study Sites (1)

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