Clinical trial NCT01345877: Pain Sensitivity in Acute Inflammatory Pain
Official title: Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers Are Studied
Keywords: burn injury
cold pressor test
gender
pain
pain sensitivity
pain prediction
psychometrics
quantitative sensory testing
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Norpharma A/S
First posted: 2011-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility 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

Primary outcomes:
measure: pain following burn injury
timeFrame: from baseline to 420 s after burn injury
Secondary outcomes:
measure: thermal thresholds
timeFrame: followed for 180 min after burn injury
measure: tactile thresholds
timeFrame: followed for 180 min after burn injury
measure: pressure algometry assessments
timeFrame: 95 min prior to burn injury
measure: DNIC-efficiency
timeFrame: 45 min before burn injury
measure: cold pressor test
timeFrame: 85 min before burn injury
measure: HADS score
timeFrame: 2 hours before the burn injury
measure: PCS ratings
timeFrame: 2 hours before the burn injury
measure: A118G SNP
timeFrame: 8 months after inclusion completed
Other outcomes:
Locations:
city: Copenhagen O
country: Denmark
facility: Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9
Study officials:
affiliation: Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark
name: Mads U Werner, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luginbuhl M, Schnider TW, Petersen-Felix S, Arendt-Nielsen L, Zbinden AM. Comparison of five experimental pain tests to measure analgesic effects of alfentanil. Anesthesiology. 2001 Jul;95(1):22-9. doi: 10.1097/00000542-200107000-00009.
citation: Edwards RR, Fillingim RB, Ness TJ. Age-related differences in endogenous pain modulation: a comparison of diffuse noxious inhibitory controls in healthy older and younger adults. Pain. 2003 Jan;101(1-2):155-65. doi: 10.1016/s0304-3959(02)00324-x.
citation: Neziri AY, Scaramozzino P, Andersen OK, Dickenson AH, Arendt-Nielsen L, Curatolo M. Reference values of mechanical and thermal pain tests in a pain-free population. Eur J Pain. 2011 Apr;15(4):376-83. doi: 10.1016/j.ejpain.2010.08.011. Epub 2010 Oct 6.
citation: Neziri AY, Curatolo M, Nuesch E, Scaramozzino P, Andersen OK, Arendt-Nielsen L, Juni P. Factor analysis of responses to thermal, electrical, and mechanical painful stimuli supports the importance of multi-modal pain assessment. Pain. 2011 May;152(5):1146-1155. doi: 10.1016/j.pain.2011.01.047. Epub 2011 Mar 10.
citation: Ravn P, Frederiksen R, Skovsen AP, Christrup LL, Werner MU. Prediction of pain sensitivity in healthy volunteers. J Pain Res. 2012;5:313-26. doi: 10.2147/JPR.S33925. Epub 2012 Aug 29.