Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Superficial blood perfusion |
Superficial blood perfusion is measured by a Speckle contrast imager (FLPI, Moor Instruments, England). |
15 minutes |
|
Primary |
Measuring itch intensity by computerized Visual Analog Scale Scoring |
The subjects will rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable" and similarly for sensations of stinging/pricking and burning, both of which are frequently associated with the sensation of itch. |
15 minutes |
|
Primary |
Measuring pain intensity by computerized Visual Analog Scale Scoring |
The subjects will rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable". |
15 minutes |
|
Primary |
Measuring Alloknesis |
Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force). This stimulator is applied 0.5 cm outside the area of itch provocation. |
15 minutes |
|
Secondary |
Measurement of Cold Detection Thresholds (CDT) |
The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 0°C will be used. |
15 minutes |
|
Secondary |
Measurement of Cold PainThresholds (CPT) |
The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 0°C will be used. |
15 minutes |
|
Secondary |
Measurement of Heat Pain Thresholds (HPT) |
The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 52°C will be used. |
15 minutes |
|
Secondary |
Measurement of Warm Detection Thresholds (WDT) |
The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 52°C will be used. |
15 minutes |
|
Secondary |
Measurement of Pain to Supra-threshold Heat Stimuli |
The tests will be conducted by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. The subjects will have to rate the pain to two suprathreshold heat pain stimuli (starting and ending at 32°C with an increase and decrease of 5°C and 3 s plateau at 50°C). |
15 minutes |
|
Secondary |
Measurement of Mechanical Pain Thresholds (MPT) |
This test is conducted using a pin-prick set (Aalborg University, Aalborg). This test is conducted using a pin-prick set (Aalborg University, Aalborg).easurement of Mechanical Pain Thresholds (MPT) |
15 minutes |
|
Secondary |
Measurement of Mechanical Pain Sensitivity (MPS) |
This test is conducted using a pin-prick set (Aalborg University, Aalborg). |
15 minutes |
|
Secondary |
Touch Pleasantness (TP) |
Pleasant touch sensation measured using astandardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN. |
15 minutes |
|