Pain Sensitivity in Acute Inflammatory Pain

Not Applicable

Completed

• Conditions: Healthy Volunteers Are Studied
• Interventions: Procedure: first degree cutaneous burn injury

• Registration Number: NCT01345877
• Lead Sponsor: University of Copenhagen

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

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-07
• Study Completion: 2011-02
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gender	first degree cutaneous burn injury	-

Primary Outcome Measures

Name	Time	Method
pain following burn injury	from baseline to 420 s after burn injury

Secondary Outcome Measures

Name	Time	Method
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
HADS score	2 hours before the burn injury
PCS ratings	2 hours before the burn injury
cold pressor test	85 min before burn injury

Trial Locations

Locations (1)

Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9; 🇩🇰 Copenhagen O, Denmark