Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| University of Copenhagen | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiemental pain models | Experimental | all study participants will be tested with the same experimental pain models: Brief thermal sensitization, Long thermal stimulation, and Heat-pain-detection threshold. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief thermal sensitization | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in area of secondary hyperalgesia following brief thermal sensitization | 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. | Study day 1, 2, 3, and 4. A minimum of 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Pain Catastrophizing Scale | How precise does the score of the Pain Catastrophizing Scale predict the size of the area of secondary hyperalgesia? | 7 days |
| Score of Hospital Anxiety and Depression Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jørgen B Dahl, MD, Doc. Med, Consultant | Department of anaesthesiology, dep. Z, Bispebjerg Hospital, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of anaesthesia and surgery, 4231, Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27167119 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D006930 | Hyperalgesia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Long thermal stimulation | Other | 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. |
|
|
| Heat-pain-detection threshold | Other | 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. |
|
|
How precise does the score of the Hospital Anxiety and Depression Scale predict the size of the area of secondary hyperalgesia?
| 7 days |
| Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale | 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? | 7 days |
| Heat-pain-detection threshold registered by degrees celsius | 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. | 1 minute per session |
| Pain following Long Thermal Stimulation, evaluated by maximum on the visual analog scale | 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. | 1 minute per session |
| Pain following Long Thermal Stimulation, evaluated by Area under the curve of the visual analog scale. | 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. | 1 minute per session |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |