Pain Sensitivity in Acute Inflammatory Pain (PASORI)
Primary Purpose
Healthy Volunteers Are Studied
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
first degree cutaneous burn injury
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers Are Studied focused on measuring burn injury, cold pressor test, gender, pain, pain sensitivity, pain prediction, psychometrics, quantitative sensory testing
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
Sites / Locations
- Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
gender
Arm Description
Outcomes
Primary Outcome Measures
pain following burn injury
Secondary Outcome Measures
thermal thresholds
tactile thresholds
pressure algometry assessments
DNIC-efficiency
cold pressor test
HADS score
PCS ratings
A118G SNP
Full Information
NCT ID
NCT01345877
First Posted
April 28, 2011
Last Updated
November 23, 2016
Sponsor
University of Copenhagen
Collaborators
Norpharma A/S
1. Study Identification
Unique Protocol Identification Number
NCT01345877
Brief Title
Pain Sensitivity in Acute Inflammatory Pain
Acronym
PASORI
Official Title
Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Norpharma A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers Are Studied
Keywords
burn injury, cold pressor test, gender, pain, pain sensitivity, pain prediction, psychometrics, quantitative sensory testing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gender
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
first degree cutaneous burn injury
Other Intervention Name(s)
Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)
Intervention Description
application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
Primary Outcome Measure Information:
Title
pain following burn injury
Time Frame
from baseline to 420 s after burn injury
Secondary Outcome Measure Information:
Title
thermal thresholds
Time Frame
followed for 180 min after burn injury
Title
tactile thresholds
Time Frame
followed for 180 min after burn injury
Title
pressure algometry assessments
Time Frame
95 min prior to burn injury
Title
DNIC-efficiency
Time Frame
45 min before burn injury
Title
cold pressor test
Time Frame
85 min before burn injury
Title
HADS score
Time Frame
2 hours before the burn injury
Title
PCS ratings
Time Frame
2 hours before the burn injury
Title
A118G SNP
Time Frame
8 months after inclusion completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mads U Werner, MD, DMSc
Organizational Affiliation
Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9
City
Copenhagen O
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
11465562
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.
Results Reference
background
PubMed Identifier
12507710
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.
Results Reference
background
PubMed Identifier
20932788
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.
Results Reference
background
PubMed Identifier
21396782
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.
Results Reference
background
PubMed Identifier
23055774
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.
Results Reference
result
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Pain Sensitivity in Acute Inflammatory Pain
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