HealthyNCT02527395
Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia
A study testing Brief thermal sensitization, Pain during 1 min. thermal stimulation and Heat pain detection threshold in people with Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this prospective study is to investigate how close Heat Pain Detection Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization. Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min. 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
- Healthy
- What is being tested?
- Brief thermal sensitization, Pain during 1 min. thermal stimulation and Heat pain detection threshold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Dec 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
- Study participants who have understood and signed the informed consent
- No prescription medicine during the last 30 days.
Who cannot join
- Study participants that cannot cooperate to the test.
- Study participants who have a weekly intake of >21 units of alcohol, or a have consumed >3 units of alcohol within 24 hours before experimental day.
- Study participants with a substance abuse, assessed by the investigator.
- Study participants, who have consumed analgesics less than 3 days before experimental day.
- Study participants, who have consumed antihistamines less than 48 hours before experimental day.
- Study participants, who have consumed antidepressant medication during the last 30 days before experimental day.
Show all 12Show fewer
- Study participants with chronic pain.
- Study participants with neurological illnesses.
- Study participants with psychiatric diagnoses.
- Study participants with tattoos on the extremities.
- Study participants with eczema, wounds or sunburns on the sites of stimulation.
- Study participants with a Body Mass Index of >30 kg/m2 or <18 kg/m2
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of anaesthesia and surgery, 4231, Rigshospitalet
Copenhagen, 2100
About this study
Official title: To Determine the Degree of Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia Following Brief Thermal Sensitization in Healthy Male Volunteers
The purpose of this prospective study is to investigate how close Heat Pain Detection Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.
Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min. heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.
Read the detailed description
The study participants will be tested with 3 types of clinical pain models on two separate identical study days. A minimum of 7 days will separate the two study days, thus, the minimum length of the study is 7 days, but can be higher.
The 3 types of pain conditioning consist of 1) Brief thermal sensitisation (BTS), 2) Heat pain detection threshold (HPDT), and pain during 1 min. thermal stimulation (p-TS.
The order of the stimulations (HPDT and BTS) is randomised for each patient and each study day, by a random allocation sequence, computer-generated by Copenhagen Trial Unit and stored in sealed and opaque envelopes to secure adequate allocation concealment. p-TS is conducted subsequent to BTS and HPDT.
The participants will complete the psychological tests Pain Catastrophizing Scale (PCS) and Hospital Anxiety and Depression Scale (HADS) in their private home prior to study day 1. The completed tests will be placed in opaque sealed envelopes to secure blinding of the investigator and outcome assessor.
- Conditions
- Healthy
- Being tested
- Brief thermal sensitization, Pain during 1 min. thermal stimulation, Heat pain detection threshold
- Keywords
- Experimental pain, Men
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief thermal sensitizationOther
Also called Clinical 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.
Pain during 1 min. thermal stimulationOther
Also called Clinical 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 Clinical 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 group | Role | What they receive |
|---|---|---|
| Clinical pain models | Other | Brief thermal sensitization. Heat pain detection threshold. Pain during 1 min. thermal stimulation Receives: Other: Brief thermal sensitization; Other: Pain during 1 min. thermal stimulation; Other: Heat pain detection threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius.
How close is the Heat Pain Detection Threshold associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization? Area of secondary hyperalgesia will be investigated on two separate study days separated with a minimum of 7 days. The association will be expressed in R2 and prediction intervals for the area of BTS given fixed values of HPDT.
Measured: 7 days
Secondary outcomes (5)
Pain during 1 min. thermal stimulation, evaluated by Area Under the Curve of the visual analog scale, 0-100 mm.
How close is the Visual analog scale (VAS)-AUC (area under the curve) following pain during 1 min. thermal stimulation associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?
Measured: Study day 1 and 2. A minimum of 7 days
Pain during 1 min. thermal stimulation, evaluated by maximum on the visual analog scale, 0-100mm.
How close is the max. VAS-score following pain during 1 min. thermal stimulation associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?
Measured: Study day 1 and 2. A minimum of 7 days.
Score of Pain Catastrophizing Scale
How close is the scores of Pain Catastrophizing Scale associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?
Measured: Study day 1 and 2. A minimum of 7 days.
Score of Hospital Anxiety and Depression Scale
How close is the scores of Hospital Anxiety and Depression Scale associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?
Measured: Study day 1 and 2. A minimum of 7 days.
Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale.
How close are the subscales in the two psychological tests (PCS-rumination, PCS-magnification, PCS-helplessness, and HADS-Anxiety, HADS-Depression) associated with the size of the area of secondary hyperalgesia?
Measured: Study day 1 and 2. A minimum of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
- Responsible party
- Principal investigator, Morten Sejer Hansen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527395
- Sponsor's protocol ID
- SM2-MSH-2014
- Status last verified
- Aug 2016
- First submitted
- 14 Aug 2015
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen MS, Asghar MS, Wetterslev J, Pipper CB, Johan Martensson J, Becerra L, Christensen A, Nybing JD, Havsteen I, Boesen M, Dahl JB. Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - Protocol for a 3-Tesla MRI Study of Healthy Volunteers. JMIR Res Protoc. 2016 Jun 17;5(2):e117. doi: 10.2196/resprot.5680.
PubMed 27317630Hansen MS, Wetterslev J, Pipper CB, Asghar MS, Dahl JB. Is heat pain detection threshold associated with the area of secondary hyperalgesia following brief thermal sensitization? A study of healthy volunteers - design and detailed plan of analysis. BMC Anesthesiol. 2016 May 31;16(1):28. doi: 10.1186/s12871-016-0193-2.
PubMed 27246322
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Degree of Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia Following Brief Thermal Sensitization in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02527395
- Acronym / sponsor ID
- SM2-MSH-2014
- Conditions
- Healthy
- Keywords
- Experimental pain, Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Aug 2015 (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.
The purpose of this prospective study is to investigate how close Heat Pain Detection Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.
Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min. heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.
Detailed description
The study participants will be tested with 3 types of clinical pain models on two separate identical study days. A minimum of 7 days will separate the two study days, thus, the minimum length of the study is 7 days, but can be higher.
The 3 types of pain conditioning consist of 1) Brief thermal sensitisation (BTS), 2) Heat pain detection threshold (HPDT), and pain during 1 min. thermal stimulation (p-TS.
The order of the stimulations (HPDT and BTS) is randomised for each patient and each study day, by a random allocation sequence, computer-generated by Copenhagen Trial Unit and stored in sealed and opaque envelopes to secure adequate allocation concealment. p-TS is conducted subsequent to BTS and HPDT.
The participants will complete the psychological tests Pain Catastrophizing Scale (PCS) and Hospital Anxiety and Depression Scale (HADS) in their private home prior to study day 1. The completed tests will be placed in opaque sealed envelopes to secure blinding of the investigator and outcome assessor.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical pain models | Other | Other: Brief thermal sensitization, Other: Pain during 1 min. thermal stimulation, Other: Heat pain detection thresholdBrief thermal sensitization. Heat pain detection threshold. Pain during 1 min. thermal stimulation |
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
- Study participants who have understood and signed the informed consent
- No prescription medicine during the last 30 days.
Key exclusion criteria (12 listed)
- Study participants that cannot cooperate to the test.
- Study participants who have a weekly intake of >21 units of alcohol, or a have consumed >3 units of alcohol within 24 hours before experimental day.
- Study participants with a substance abuse, assessed by the investigator.
- Study participants, who have consumed analgesics less than 3 days before experimental day.
- Study participants, who have consumed antihistamines less than 48 hours before experimental day.
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: Clinical 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 | Clinical pain models |
| Pain during 1 min. thermal stimulationAlso: Clinical 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 | Clinical pain models |
| Heat pain detection thresholdAlso: Clinical 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 | Clinical pain models |
Primary outcome
Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius.
Time frame: 7 days
How close is the Heat Pain Detection Threshold associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization? Area of secondary hyperalgesia will be investigated on two separate study days separated with a minimum of 7 days. The association will be expressed in R2 and prediction intervals for the area of BTS given fixed values of HPDT.
5 secondary outcomes
Pain during 1 min. thermal stimulation, evaluated by Area Under the Curve of the visual analog scale, 0-100 mm.
Time frame: Study day 1 and 2. A minimum of 7 days
Pain during 1 min. thermal stimulation, evaluated by maximum on the visual analog scale, 0-100mm.
Time frame: Study day 1 and 2. A minimum of 7 days.
Score of Pain Catastrophizing Scale
Time frame: Study day 1 and 2. A minimum of 7 days.
Score of Hospital Anxiety and Depression Scale
Time frame: Study day 1 and 2. A minimum of 7 days.
Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale.
Time frame: Study day 1 and 2. A minimum of 7 days.
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 25 Aug 2016.
- Derived from this study: PubMed 27317630Hansen MS, Asghar MS, Wetterslev J, Pipper CB, Johan Martensson J, Becerra L, Christensen A, Nybing JD, Havsteen I, Boesen M, Dahl JB. Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - Protocol for a 3-Tesla MRI Study of Healthy Volunteers. JMIR Res Protoc. 2016 Jun 17;5(2):e117. doi: 10.2196/resprot.5680.
- Derived from this study: PubMed 27246322Hansen MS, Wetterslev J, Pipper CB, Asghar MS, Dahl JB. Is heat pain detection threshold associated with the area of secondary hyperalgesia following brief thermal sensitization? A study of healthy volunteers - design and detailed plan of analysis. BMC Anesthesiol. 2016 May 31;16(1):28. doi: 10.1186/s12871-016-0193-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief thermal sensitization, Pain during 1 min. thermal stimulation and Heat pain detection threshold in people with Healthy, run by Copenhagen University Hospital, Rigshospitalet 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 5 inclusion and 12 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 25 Aug 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?
Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius. (time frame: 7 days). 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 NCT02527395, which also lists 2 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 25 Aug 2016.