Characterization of Secondary Hyperalgesia in Healthy Volunteers

NCT02166164 | Completed

• 1 other identifier: SM1-MSH-2014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Pain; Secondary hyperalgesia; thermal sensitization; Catastrophization; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in area of secondary hyperalgesia following brief thermal sensitization

  To determine the intra- and inter-individual variance, and the inter- and intra-observer variance of the secondary hyperalgesia areas following brief thermal sensitization on 4 separate experimental days with two different observers.

  Study day 1, 2, 3, and 4. A minimum of 4 weeks.

Secondary Outcomes (6)

• Score of Pain Catastrophizing Scale

  7 days

• Score of Hospital Anxiety and Depression Scale

  7 days

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

  7 days

• Heat-pain-detection threshold registered by degrees celsius

  1 minute per session

• Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale

  1 minute per session

Study Arms (1)

Experiemental pain models

EXPERIMENTAL

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

Other: Brief thermal sensitization; Other: Long thermal stimulation; Other: Heat-pain-detection threshold

Interventions

Brief thermal sensitization 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.

Also known as: Experimental thermal pain model

Experiemental pain models

Long thermal stimulation 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.

Also known as: Experimental pain model

Experiemental pain models

Heat-pain-detection threshold 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.

Also known as: Experimental pain model

Experiemental pain models

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Department of anaesthesia and surgery, 4231, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27167119 DERIVED

MeSH Terms

Conditions

Pain; Hyperalgesia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jørgen B Dahl, MD, Doc. Med, Consultant

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

DK (1)