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Pain Sensitivity in Acute Inflammatory Pain (PASORI)

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ClinicalTrials.gov Identifier: NCT01345877
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : November 28, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Healthy Volunteers Are Studied Procedure: first degree cutaneous burn injury

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests
Study Start Date : February 2010
Primary Completion Date : July 2010
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Burns
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
gender Procedure: first degree cutaneous burn injury
application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
Other Name: Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)

Outcome Measures

Primary Outcome Measures :
  1. pain following burn injury [ Time Frame: from baseline to 420 s after burn injury ]

Secondary Outcome Measures :
  1. thermal thresholds [ Time Frame: followed for 180 min after burn injury ]
  2. tactile thresholds [ Time Frame: followed for 180 min after burn injury ]
  3. pressure algometry assessments [ Time Frame: 95 min prior to burn injury ]
  4. DNIC-efficiency [ Time Frame: 45 min before burn injury ]
  5. cold pressor test [ Time Frame: 85 min before burn injury ]
  6. HADS score [ Time Frame: 2 hours before the burn injury ]
  7. PCS ratings [ Time Frame: 2 hours before the burn injury ]
  8. A118G SNP [ Time Frame: 8 months after inclusion completed ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345877

Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9
Copenhagen O, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
Norpharma A/S
Principal Investigator: Mads U Werner, MD, DMSc Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark
More Information

Responsible Party: mads u werner, MD, DMSci, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01345877     History of Changes
Other Study ID Numbers: H-1-2009-132
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by mads u werner, University of Copenhagen:
burn injury
cold pressor test
pain sensitivity
pain prediction
quantitative sensory testing

Additional relevant MeSH terms:
Immune System Diseases