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Completed

NCT Number: NCT02166164

Characterization of Secondary Hyperalgesia in Healthy Volunteers

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.

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Key information

Conditions

Experimental Pain in Healthy Males Anxiety Disorders Hyperalgesia Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of anaesthesia and surgery, 4231, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Experimental thermal pain model

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.

Other names: Experimental pain model

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.

Other names: Experimental pain model

Primary outcomes

  1. Change in area of secondary hyperalgesia following brief thermal sensitization

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

    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.

Secondary outcomes

  1. Score of Pain Catastrophizing Scale

    Time frame: 7 days

    How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?

  2. Score of Hospital Anxiety and Depression Scale

    Time frame: 7 days

    How precise does the score of the Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia?

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

    Time frame: 7 days

    How precise do the subscales in the two psychological tests (PCS-rumination, PCS-magnification, PCS-helplessness, and HADS-Anxiety, HADS-Depression) predict the size of the area of secondary hyperalgesia?

  4. Heat-pain-detection threshold registered by degrees celsius

    Time frame: 1 minute per session

    How precise do the Heat-pain-detection threshold evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Heat-pain-detection threshold on 4 separate experimental days with 1 session per experimental day.

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

    Time frame: 1 minute per session

    How precise does the Max. VAS-score following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per experimental day.

  6. Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.

    Time frame: 1 minute per session

    How precise does the VAS-Area Under the Curve following Long Thermal Stimulation evaluated on the 4 experimental days predict the size of the area of secondary hyperalgesia on the respective 4 experimental days? 4 sessions of Long Thermal Stimulation on 4 separate experimental days with 1 session per study day.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2014
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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