Characterization of Secondary Hyperalgesia in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in area of secondary hyperalgesia following brief thermal sensitization
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Morten Sejer Hansen
MD
Rigshospitalet, Denmark