Experimental Pain in Healthy MalesNCT02166164

Characterization of Secondary Hyperalgesia in Healthy Volunteers

A study testing Brief thermal sensitization, Long thermal stimulation and Heat-pain-detection threshold in people with Experimental Pain in Healthy Males, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this prospective trial we aim to investigate the intra-individual and inter-individual variance in secondary hyperalgesia following pain elicited by the experimental pain model: Brief Thermal Sensitization. Read more about this study

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Experimental Pain in Healthy Males
What is being tested?: Brief thermal sensitization, Long thermal stimulation and Heat-pain-detection threshold
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteDenmark
Study dates: Jun 2014to Jan 2015
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 18 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Age >18 years and <35 years
Speak and understand Danish
Male gender
Test subjects who have understood and signed the informed consent
No prescription medicine during the last 30 days

Who cannot join

Test subjects that cannot cooperate to the test
Test subjects with an alcohol and/or substance abuse, assessed by the investigator
Test subjects, who have consumed one or several types of analgesics 2 <days before the study
Test subjects, who have consumed antidepressant medication during the last 30 days before the study
Test subjects with chronic pain
Test subjects with psychiatric diagnoses
Test subjects with tattoos on the extremities
Body Mass Index of >30 or <18

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of anaesthesia and surgery, 4231, Rigshospitalet
Copenhagen, 2100

Other trials in Denmark

About this study

Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia.

Conditions: Experimental Pain in Healthy Males
Being tested: Brief thermal sensitization, Long thermal stimulation, Heat-pain-detection threshold
Keywords: Pain, Secondary hyperalgesia, thermal sensitization, Catastrophization, Anxiety
Medical subject headings: Pain, Hyperalgesia, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief thermal sensitizationOther
Also called Experimental thermal pain model
A small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.
Long thermal stimulationOther
Also called Experimental pain model
A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.
Heat-pain-detection thresholdOther
Also called Experimental pain model
The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered.
4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.

Study groups in NCT02166164
Study group	Role	What they receive
Experiemental pain models	Experimental	all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold. Receives: Other: Brief thermal sensitization; Other: Long thermal stimulation; Other: Heat-pain-detection threshold

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in area of secondary hyperalgesia following brief thermal sensitization
To determine the intra- and inter-individual variance, and the inter- and intra-observer variance of the secondary hyperalgesia areas following brief thermal sensitization on 4 separate experimental days with two different observers.
Measured: Study day 1, 2, 3, and 4. A minimum of 4 weeks.

Secondary outcomes (6)

Score of Pain Catastrophizing Scale
How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?
Measured: 7 days
Score of Hospital Anxiety and Depression Scale
How precise does the score of the Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia?
Measured: 7 days
Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale
How precise do the subscales in the two psychological tests (PCS-rumination, PCS-magnification, PCS-helplessness, and HADS-Anxiety, HADS-Depression) predict the size of the area of secondary hyperalgesia?
Measured: 7 days
Heat-pain-detection threshold registered by degrees celsius
How precise do the Heat-pain-detection threshold evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Heat-pain-detection threshold on 4 separate experimental days with 1 session per experimental day.
Measured: 1 minute per session
Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale
How precise does the Max. VAS-score following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per experimental day.
Measured: 1 minute per session
Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.
How precise does the VAS-Area Under the Curve following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per study day.
Measured: 1 minute per session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jan 2015

First posted18 Jun 2014 (estimated)
Study startJun 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Experimental Pain in Healthy MalesStudies of the same condition, open and under way.
More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
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: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02166164
Sponsor's protocol ID: SM1-MSH-2014
Status last verified: Jan 2015
First submitted: 12 Jun 2014
Last updated: 27 Jan 2015
Results posted: No
Data monitoring committee: No

Publications

Hansen MS, Wetterslev J, Pipper CB, Ostervig R, Asghar MS, Dahl JB. The Area of Secondary Hyperalgesia following Heat Stimulation in Healthy Male Volunteers: Inter- and Intra-Individual Variance and Reproducibility. PLoS One. 2016 May 11;11(5):e0155284. doi: 10.1371/journal.pone.0155284. eCollection 2016.
PubMed 27167119

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of Secondary Hyperalgesia in Healthy Volunteers
ClinicalTrials.gov ID: NCT02166164
Acronym / sponsor ID: SM1-MSH-2014
Conditions: Experimental Pain in Healthy Males
Keywords: Pain, Secondary hyperalgesia, thermal sensitization, Catastrophization, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (estimated)
Lead sponsor: Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
Study start: Jun 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 18 Jun 2014 (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.

Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experiemental pain models	Experimental	Other: Brief thermal sensitization, Other: Long thermal stimulation, Other: Heat-pain-detection thresholdall study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age >18 years and <35 years
Speak and understand Danish
Male gender
Test subjects who have understood and signed the informed consent
No prescription medicine during the last 30 days

Key exclusion criteria (8 listed)

Test subjects that cannot cooperate to the test
Test subjects with an alcohol and/or substance abuse, assessed by the investigator
Test subjects, who have consumed one or several types of analgesics 2 <days before the study
Test subjects, who have consumed antidepressant medication during the last 30 days before the study
Test subjects with chronic pain

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
Brief thermal sensitizationAlso: Experimental thermal pain modelA small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.	Other	Experiemental pain models
Long thermal stimulationAlso: Experimental pain modelA small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.	Other	Experiemental pain models
Heat-pain-detection thresholdAlso: Experimental pain modelThe threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered. 4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.	Other	Experiemental pain models

Primary outcome

Change in area of secondary hyperalgesia following brief thermal sensitization
Time frame: Study day 1, 2, 3, and 4. A minimum of 4 weeks.
To determine the intra- and inter-individual variance, and the inter- and intra-observer variance of the secondary hyperalgesia areas following brief thermal sensitization on 4 separate experimental days with two different observers.

6 secondary outcomes

Score of Pain Catastrophizing Scale
Time frame: 7 days
Score of Hospital Anxiety and Depression Scale
Time frame: 7 days
Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale
Time frame: 7 days
Heat-pain-detection threshold registered by degrees celsius
Time frame: 1 minute per session
Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale
Time frame: 1 minute per session
Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.
Time frame: 1 minute per session

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 27 Jan 2015.
Derived from this study: PubMed 27167119Hansen MS, Wetterslev J, Pipper CB, Ostervig R, Asghar MS, Dahl JB. The Area of Secondary Hyperalgesia following Heat Stimulation in Healthy Male Volunteers: Inter- and Intra-Individual Variance and Reproducibility. PLoS One. 2016 May 11;11(5):e0155284. doi: 10.1371/journal.pone.0155284. eCollection 2016.

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.

Jørgen B Dahl, MD, Doc. Med, Consultant study director

Department of anaesthesiology, dep. Z, Bispebjerg Hospital, Denmark

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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 27 Jan 2015. 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?

Change in area of secondary hyperalgesia following brief thermal sensitization (time frame: Study day 1, 2, 3, and 4. A minimum of 4 weeks.). 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 NCT02166164, which also lists 1 linked publication.

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 27 Jan 2015.