Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia

August 24, 2016 updated by: Morten Sejer Hansen, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinical pain models
Brief thermal sensitization. Heat pain detection threshold. Pain during 1 min. thermal stimulation
Other: Brief thermal sensitization
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.
Other Names:
  • Clinical pain model
Other: Pain during 1 min. thermal stimulation
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.
Other Names:
  • Clinical pain model
Other: Heat pain detection threshold
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.
Other Names:
  • Clinical pain model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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?
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.
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?
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.
How close is the scores of Pain Catastrophizing Scale associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?
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.
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?
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.
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?
Study day 1 and 2. A minimum of 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM2-MSH-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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