Pain Sensitivity in Acute Inflammatory Pain (PASORI)

This study has been completed.
Sponsor:
Collaborator:
Norpharma A/S
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01345877
First received: April 28, 2011
Last updated: April 29, 2011
Last verified: February 2011
  Purpose

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 Intervention
Healthy Volunteers Are Studied
Procedure: first degree cutaneous burn injury

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • pain following burn injury [ Time Frame: from baseline to 420 s after burn injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • thermal thresholds [ Time Frame: followed for 180 min after burn injury ] [ Designated as safety issue: No ]
  • tactile thresholds [ Time Frame: followed for 180 min after burn injury ] [ Designated as safety issue: No ]
  • pressure algometry assessments [ Time Frame: 95 min prior to burn injury ] [ Designated as safety issue: No ]
  • DNIC-efficiency [ Time Frame: 45 min before burn injury ] [ Designated as safety issue: No ]
  • cold pressor test [ Time Frame: 85 min before burn injury ] [ Designated as safety issue: No ]
  • HADS score [ Time Frame: 2 hours before the burn injury ] [ Designated as safety issue: No ]
  • PCS ratings [ Time Frame: 2 hours before the burn injury ] [ Designated as safety issue: No ]
  • A118G SNP [ Time Frame: 8 months after inclusion completed ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345877

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

Publications:
Responsible Party: Mads U. Werner MD, DMSc, Multidisciplinary Pain Center 7162, Neuroscience Center, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen O
ClinicalTrials.gov Identifier: NCT01345877     History of Changes
Other Study ID Numbers: H-1-2009-132
Study First Received: April 28, 2011
Last Updated: April 29, 2011
Health Authority: Denmark: Ministry of Science, Technology and Innovation
Denmark: The Danish Medicines Agency

Keywords provided by University of Copenhagen:
burn injury
cold pressor test
gender
pain
pain sensitivity
pain prediction
psychometrics
quantitative sensory testing

ClinicalTrials.gov processed this record on July 31, 2014