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Clinical Trials/NCT02166164
NCT02166164
Completed
N/A

Characterization of Secondary Hyperalgesia in Healthy Volunteers

Rigshospitalet, Denmark1 site in 1 country50 target enrollmentJune 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Experimental Pain in Healthy Males
Sponsor
Rigshospitalet, Denmark
Enrollment
50
Locations
1
Primary Endpoint
Change in area of secondary hyperalgesia following brief thermal sensitization
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
January 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Morten Sejer Hansen

MD

Rigshospitalet, Denmark

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

Outcomes

Primary Outcomes

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

  • Score of Pain Catastrophizing Scale(7 days)
  • Heat-pain-detection threshold registered by degrees celsius(1 minute per session)
  • Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.(1 minute per session)
  • Score of Hospital Anxiety and Depression Scale(7 days)
  • Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale(1 minute per session)
  • Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale(7 days)

Study Sites (1)

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