Open Label Placebo application has been shown to be effective in treatment of chronic pain (low back pain) and disease like the irritable bowel Syndrome. Data about effects on acute pain are spare. The study investigates the effect of an open-label Placebo (substance without a medical active component) application on acute pain, evoked via a artificial pain model in healthy male volunteers. 32 healthy male volunteers are recruited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
c.p. intervention description
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Pain response measured by the Area under the Pain Curve (AUPC)
Pain response measured by creating the Area under the Pain Curve (AUPC), using the numeric rating scale (NRS) from minute 30 to 100 during constant induced pain with electrical current at the forearm of the participant. Measuring of pain every 10 minutes from minute 30 to 100 (Minute 30,40,50,60,70,80,90, 100) in an experimental setting. Main comparison: The effect of open label placebo v.s. no treatment intervention
Time frame: 30 minutes after baseline until 100 minutes after baseline
Differences in pain response measured by the AUPC due to education
The pain response measured by the AUPC in participants received a detailed education about open label Placebo compared to those who received a short education direct prior to placebo administration.
Time frame: 30 minutes after baseline until 100 minutes after baseline
hyperalgesia
Hyperalgesia will be measured analogously to the NRS
Time frame: 100min
Saliva cortisol concentration in μg/dL
Saliva concentration of cortisol, will be measured 4 times: at baseline, 30, 60 and 100 minutes during pain induction
Time frame: baseline until 100 min after baseline
allodynia
allodynia will be measured analogously to the NRS
Time frame: 100minutes
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