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Completed

NCT Number: NCT01345877

Pain Sensitivity in Acute Inflammatory Pain

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.

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Key information

Conditions

Healthy Volunteers Are Studied Behavior Burns Coitus Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms Wounds and Injuries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9

Copenhagen O, 2100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

first degree cutaneous burn injury

Procedure

application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s

Other names: Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)

Primary outcomes

  1. pain following burn injury

    Time frame: from baseline to 420 s after burn injury

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Norpharma A/S

Registry information

Official study title

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

Acronym: PASORI

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 2, 2011
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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