Characterization of Secondary Hyperalgesia in Healthy Volunteers

NCT ID: NCT02166164

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experiemental pain models

all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.

Group Type: EXPERIMENTAL

Brief thermal sensitization

Intervention Type: OTHER

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 stimulation

Intervention Type: OTHER

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 threshold

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Long 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Experimental thermal pain model; Experimental pain model; Experimental pain model

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Morten Sejer Hansen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jørgen B Dahl, MD, Doc. Med, Consultant

Role: STUDY_DIRECTOR

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

Locations

Department of anaesthesia and surgery, 4231, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 27167119 (View on PubMed)

Other Identifiers

SM1-MSH-2014

Identifier Type: -

Identifier Source: org_study_id