NCT01345877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

April 28, 2011

Last Update Submit

November 23, 2016

Conditions

Healthy Volunteers Are Studied

Keywords

burn injurycold pressor testgenderpainpain sensitivitypain predictionpsychometricsquantitative sensory testing

Outcome Measures

Primary Outcomes (1)

  • pain following burn injury

    from baseline to 420 s after burn injury

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

gender

OTHER
Procedure: first degree cutaneous burn injury

Interventions

first degree cutaneous burn injuryPROCEDURE

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

Also known as: Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)
gender

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • psychomotor ability to perform the tests
  • cognitive ability to perform the tests

You may not qualify if:

  • smoker
  • Body Mass Index \> 28
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen O, 2100, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 11465562BACKGROUND

  • 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.

    PMID: 12507710BACKGROUND

  • 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.

    PMID: 20932788BACKGROUND

  • 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.

    PMID: 21396782BACKGROUND

  • 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.

    PMID: 23055774RESULT

MeSH Terms

Conditions

BurnsCoitusPain

Condition Hierarchy (Ancestors)

Wounds and InjuriesSexual BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mads U Werner, MD, DMSc

    Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSci

Study Record Dates

First Submitted

April 28, 2011

First Posted

May 2, 2011

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

February 1, 2011

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

DK(1)