Pain Sensitivity in Acute Inflammatory Pain (PASORI)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers Are Studied
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen O, Denmark, 2100
    • Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain following burn injury	from baseline to 420 s after burn injury

Secondary Outcome Measures

Outcome Measure	Time Frame
thermal thresholds	followed for 180 min after burn injury
tactile thresholds	followed for 180 min after burn injury
pressure algometry assessments	95 min prior to burn injury
DNIC-efficiency	45 min before burn injury
cold pressor test	85 min before burn injury
HADS score	2 hours before the burn injury
PCS ratings	2 hours before the burn injury
A118G SNP	8 months after inclusion completed

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Norpharma A/S
• Investigators: Principal Investigator: Mads U Werner, MD, DMSc, Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: pain; psychometrics; quantitative sensory testing; gender; burn injury; cold pressor test; pain sensitivity; pain prediction
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: H-1-2009-132