Characterization of Secondary Hyperalgesia in Healthy Volunteers

Not Applicable

Completed

• Conditions: Experimental Pain in Healthy Males
• Interventions: Other: Brief thermal sensitization; Other: Long thermal stimulation; Other: Heat-pain-detection threshold

• Registration Number: NCT02166164
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-18
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in area of secondary hyperalgesia following brief thermal sensitization	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 Outcome Measures

Name	Time	Method
Score of Pain Catastrophizing Scale	7 days	How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia?
Heat-pain-detection threshold registered by degrees celsius	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.
Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale.	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.
Score of Hospital Anxiety and Depression Scale	7 days	How precise does the score of the Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia?
Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale	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.
Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale	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?

Trial Locations

Locations (1)

Department of anaesthesia and surgery, 4231, Rigshospitalet; 🇩🇰 Copenhagen, Denmark