Healthy Volunteers Are StudiedPASORINCT01345877
Pain Sensitivity in Acute Inflammatory Pain
A study testing first degree cutaneous burn injury in people with Healthy Volunteers Are Studied, run by University of Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Are Studied
- What is being tested?
- first degree cutaneous burn injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- psychomotor ability to perform the tests
- cognitive ability to perform the tests
Who cannot join
- smoker
- Body Mass Index > 28
- participation in drug studies < 4 weeks prior to inclusion
- chronic pain
- chronic intake of analgesics
- drug or alcohol abuse
Show all 9Show fewer
- intake of analgesics < 48 hours prior to study
- females not on contraceptive therapy (intra-uterine device or p-pill)
- lesion in the assessment area
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9
Copenhagen O, 2100
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy Volunteers Are Studied
- Being tested
- first degree cutaneous burn injury
- Keywords
- burn injury, cold pressor test, gender, pain, pain sensitivity, pain prediction, psychometrics, quantitative sensory testing
- Medical subject headings
- Burns, Coitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first degree cutaneous burn injuryProcedure or surgery
Also called Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)
application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
| Study group | Role | What they receive |
|---|---|---|
| gender | Other | Not described Receives: Procedure: first degree cutaneous burn injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain following burn injury
Measured: from baseline to 420 s after burn injury
Secondary outcomes (8)
thermal thresholds
Measured: followed for 180 min after burn injury
tactile thresholds
Measured: followed for 180 min after burn injury
pressure algometry assessments
Measured: 95 min prior to burn injury
DNIC-efficiency
Measured: 45 min before burn injury
cold pressor test
Measured: 85 min before burn injury
HADS score
Measured: 2 hours before the burn injury
PCS ratings
Measured: 2 hours before the burn injury
A118G SNP
Measured: 8 months after inclusion completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers Are StudiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Norpharma A/S
- Responsible party
- Principal investigator, mads u werner, University of Copenhagen
- Investigators
- Mads U Werner, MD, DMSc, Principal investigator, Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345877
- Sponsor's protocol ID
- H-1-2009-132
- Acronym
- PASORI
- Status last verified
- Nov 2016
- First submitted
- 28 Apr 2011
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11465562Edwards 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.
PubMed 12507710Neziri 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.
PubMed 20932788Neziri 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.
PubMed 21396782Ravn 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.
PubMed 23055774
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Sensitivity in Acute Inflammatory Pain - Gender Differences and Validity of Sensory Tests
- ClinicalTrials.gov ID
- NCT01345877
- Acronym / sponsor ID
- PASORI / H-1-2009-132
- Conditions
- Healthy Volunteers Are Studied
- Keywords
- burn injury, cold pressor test, gender, pain, pain sensitivity, pain prediction, psychometrics, quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Norpharma A/S
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gender | Other | Procedure: first degree cutaneous burn injury |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- psychomotor ability to perform the tests
- cognitive ability to perform the tests
Key exclusion criteria (9 listed)
- smoker
- Body Mass Index > 28
- participation in drug studies < 4 weeks prior to inclusion
- chronic pain
- chronic intake of analgesics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| first degree cutaneous burn injuryAlso: Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s | Procedure or surgery | gender |
Primary outcome
pain following burn injury
Time frame: from baseline to 420 s after burn injury
8 secondary outcomes
thermal thresholds
Time frame: followed for 180 min after burn injury
tactile thresholds
Time frame: followed for 180 min after burn injury
pressure algometry assessments
Time frame: 95 min prior to burn injury
DNIC-efficiency
Time frame: 45 min before burn injury
cold pressor test
Time frame: 85 min before burn injury
HADS score
Time frame: 2 hours before the burn injury
PCS ratings
Time frame: 2 hours before the burn injury
A118G SNP
Time frame: 8 months after inclusion completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Background: PubMed 11465562Luginbuhl 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.
- Background: PubMed 12507710Edwards 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.
- Background: PubMed 20932788Neziri 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.
- Background: PubMed 21396782Neziri 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 publication: PubMed 23055774Ravn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mads U Werner, MD, DMSc principal investigator
Multidsciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first degree cutaneous burn injury in people with Healthy Volunteers Are Studied, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain following burn injury (time frame: from baseline to 420 s after burn injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01345877, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016; AzTrials last refreshed its copy on 30 Oct 2026.