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Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Brief thermal sensitization
Pain during 1 min. thermal stimulation
Heat pain detection threshold
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Experimental pain, Men

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Department of anaesthesia and surgery, 4231, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinical pain models

Arm Description

Brief thermal sensitization. Heat pain detection threshold. Pain during 1 min. thermal stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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?
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?
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?
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?
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?

Full Information

First Posted
August 14, 2015
Last Updated
August 24, 2016
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02527395
Brief Title
Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Experimental pain, Men

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical pain models
Arm Type
Other
Arm Description
Brief thermal sensitization. Heat pain detection threshold. Pain during 1 min. thermal stimulation
Intervention Type
Other
Intervention Name(s)
Brief thermal sensitization
Other Intervention Name(s)
Clinical pain model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain during 1 min. thermal stimulation
Other Intervention Name(s)
Clinical pain model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Heat pain detection threshold
Other Intervention Name(s)
Clinical pain model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius.
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pain during 1 min. thermal stimulation, evaluated by Area Under the Curve of the visual analog scale, 0-100 mm.
Description
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?
Time Frame
Study day 1 and 2. A minimum of 7 days
Title
Pain during 1 min. thermal stimulation, evaluated by maximum on the visual analog scale, 0-100mm.
Description
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?
Time Frame
Study day 1 and 2. A minimum of 7 days.
Title
Score of Pain Catastrophizing Scale
Description
How close is the scores of Pain Catastrophizing Scale associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?
Time Frame
Study day 1 and 2. A minimum of 7 days.
Title
Score of Hospital Anxiety and Depression Scale
Description
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?
Time Frame
Study day 1 and 2. A minimum of 7 days.
Title
Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale.
Description
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?
Time Frame
Study day 1 and 2. A minimum of 7 days.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Facility Information:
Facility Name
Department of anaesthesia and surgery, 4231, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27317630
Citation
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.
Results Reference
derived
PubMed Identifier
27246322
Citation
Hansen 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.
Results Reference
derived

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Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia

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