Trial record 1 of 1 for:
NCT02166164
Characterization of Secondary Hyperalgesia in Healthy Volunteers
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| ClinicalTrials.gov Identifier: NCT02166164 |
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Recruitment Status :
Completed
First Posted : June 18, 2014
Last Update Posted : January 27, 2015
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Sponsor:
Rigshospitalet, Denmark
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
Information provided by (Responsible Party):
Morten Sejer Hansen, Rigshospitalet, Denmark
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Experimental Pain in Healthy Males | Other: Brief thermal sensitization Other: Long thermal stimulation Other: Heat-pain-detection threshold | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Characterization of Secondary Hyperalgesia in Healthy Volunteers |
| Study Start Date : | June 2014 |
| Actual Primary Completion Date : | January 2015 |
| Actual Study Completion Date : | January 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experiemental pain models
all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold.
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Other: Brief thermal sensitization
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 Name: Experimental thermal pain model Other: Long thermal stimulation 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 Name: Experimental pain model Other: Heat-pain-detection threshold 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 Name: Experimental pain model |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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?
- 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?
- 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?
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166164
Locations
| Denmark | |
| Department of anaesthesia and surgery, 4231, Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
Investigators
| Study Director: | Jørgen B Dahl, MD, Doc. Med, Consultant | Department of anaesthesiology, dep. Z, Bispebjerg Hospital, Denmark |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Morten Sejer Hansen, MD, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT02166164 |
| Other Study ID Numbers: |
SM1-MSH-2014 |
| First Posted: | June 18, 2014 Key Record Dates |
| Last Update Posted: | January 27, 2015 |
| Last Verified: | January 2015 |
Keywords provided by Morten Sejer Hansen, Rigshospitalet, Denmark:
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Pain Secondary hyperalgesia thermal sensitization Catastrophization Anxiety |
Additional relevant MeSH terms:
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Hyperalgesia Somatosensory Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases |