Hyperalgesia, Secondary Clinical Trial
Official title:
Test-retest Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation of Skin Nociceptors
This study is designed to evaluate the method of assessing the and intensity areas of secondary hyperalgesia induced by High Frequency Stimulation (HFS). Measures of the areas of secondary hyperalgesia will take place on two experimental days separated by a minimum of two weeks. Each experimental day, the areas of secondary hyperalgesia will be assessed three times, starting 30 minutes following HFS. Furthermore, the investigators will assess if anxiety, catastrophization, stress and demographic variables modulate the extend of hyperalgesia.
This prospective cohort study is designed to evaluate the method of assessing the areas and
intensity of secondary hyperalgesia following High Frequency Stimulation (HFS), and will
consist of two experimental days separated by a minimum of two weeks. During the two each
session (Day1 and Day2), subjects will go through the HFS procedure on the same forearm.
Then, after a 30 minutes break, the area and intensity of secondary hyperalgesia induced by
HFS will be assessed three times (Time9-14), with a two-minute break between each assessment.
Before the experiment, subjects will fill two questionnaires by email : the Spielberger Trait
anxiety inventory and the Pain catastrophization scale.The first experimental day, the
patients will be seated on a chair and informed consent will be gained. Subjects will provide
demographic information to the researcher (age, gender, size) (Time1). Then, the forearm skin
of the selected arm will be marked with a pen to improve the precision of subsequent
measures. The subject will then observe a period of rest for 5 minutes, to provide a baseline
measure of heart rate variability.
Next, the patients will be asked to rate the pain induced by pin-prick stimulation in the
area surrounding the electrode (Time2).
Following standardized explanation of the HFS procedure, the subject will fill the
Spielberger State anxiety inventory (Time5), and HFS will be applied on the volar forearm
(6-10 cm distal to the cubital fossa) (Time6). To avoid any confounding effect of handedness,
the arm onto which HFS will be applied (dominant vs nondominant) will be counterbalanced
across participants. In summary, HFS will consist of 12 trains of 42 Hz electrical pulses
(pulse width: 2 ms) lasting 1 s each. The time interval between each train will 10 s. The
intensity of stimulation will be 5mA. Heart rate variability during the HFS procedure will be
monitored.
After a 25 minutes break the heart rate variability will be assessed a third time during 5
minutes. During the break, subjects will be asked to stay seated, to fill the Pain
Catastrophizing scale (short-version) and give a rating from 0-100 for the pain and stress
experienced during the HFS procedure (Time7).
Following this break, the area of secondary hyperalgesia will be assessed with a calibrated
128 mN pinprick probe (The Pin Prick, MRC Systems GmbH, Heidelger, Germany) (Time9). Pokes of
1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and
approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the
application site. Participants will be asked to keep their eyes closed during the entire
mapping procedure. Then, participants will rate the pain induced by pin-prick stimulation in
the area surrounding the electrode (Time10). This procedure will be conducted three times,
with a two-minute break between each assessment (Time 11-14).
The second experimental day (Day2), the procedure will be similar to the first, but informed
consent and the Spielberger Trait anxiety inventory and the Pain catastrophization scale will
not be filled.
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