NCT02527395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

August 14, 2015

Last Update Submit

August 24, 2016

Conditions

Healthy

Keywords

Experimental painMen

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

    Study day 1 and 2. A minimum of 7 days.

  • Score of Pain Catastrophizing Scale

    Study day 1 and 2. A minimum of 7 days.

  • Score of Hospital Anxiety and Depression Scale

    Study day 1 and 2. A minimum of 7 days.

  • Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale.

    Study day 1 and 2. A minimum of 7 days.

Study Arms (1)

Clinical pain models

OTHER

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

Other: Brief thermal sensitizationOther: Pain during 1 min. thermal stimulationOther: Heat pain detection threshold

Interventions

Brief thermal sensitizationOTHER

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.

Also known as: Clinical pain model
Clinical pain models
Pain during 1 min. thermal stimulationOTHER

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.

Also known as: Clinical pain model
Clinical pain models
Heat pain detection thresholdOTHER

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.

Also known as: Clinical pain model
Clinical pain models

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anaesthesia and surgery, 4231, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 27317630DERIVED

  • 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.

    PMID: 27246322DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 19, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

DK(1)