An interventional study of Education in Acute Pain, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 35 is below the median of 87 across 759 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Prior to the intervention during the Placebo is given, the volunteer receives a detailed information about the effect and the strength of an open-label placebo. This education is performed via a slide show and a news report video. The important terms for Placebo analgesia: positive expectations, conditioning, communication are discussed
Other: Education
No detailed Information about open-label placebo prior to the intervention. The volunteer is told about the possible strength of the Placebo effect on pain directly before the application.
Other: Education
c.p. intervention description
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Mar 2018, 4 months.
Of 314 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's 4 months is below that.
Counting every sponsor, half of 318 studies reached it within 11 months; a quarter within 5 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →