141
Participants
Start Date
March 23, 2023
Primary Completion Date
June 30, 2025
Study Completion Date
June 30, 2025
OLP-injection
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationale
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute pain
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
RECRUITING
University Hospital of Basel (USB); Department of Anaesthesiology, Basel
University Hospital, Basel, Switzerland
OTHER