Clinical trial NCT02166164: Characterization of Secondary Hyperalgesia in Healthy Volunteers
Official title: Characterization of Secondary Hyperalgesia in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental Pain in Healthy Males
Keywords: Pain
Secondary hyperalgesia
thermal sensitization
Catastrophization
Anxiety
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: University of Copenhagen
First posted: 2014-06-18
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in area of secondary hyperalgesia following brief thermal sensitization
timeFrame: Study day 1, 2, 3, and 4. A minimum of 4 weeks.
Secondary outcomes:
measure: Score of Pain Catastrophizing Scale
timeFrame: 7 days
measure: Score of Hospital Anxiety and Depression Scale
timeFrame: 7 days
measure: Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale
timeFrame: 7 days
measure: Heat-pain-detection threshold registered by degrees celsius
timeFrame: 1 minute per session
measure: Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale
timeFrame: 1 minute per session
measure: Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.
timeFrame: 1 minute per session
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of anaesthesia and surgery, 4231, Rigshospitalet
Study officials:
affiliation: Department of anaesthesiology, dep. Z, Bispebjerg Hospital, Denmark
name: Jørgen B Dahl, MD, Doc. Med, Consultant
role: STUDY_DIRECTOR
References:
citation: 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.