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RECRUITING
NCT05819476
NA

Boosting Open-Label Placebo Effects in Acute Induced Pain in Healthy Adults

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

This study is to investigate the effect of open-label placebo (OLP) application on acute pain in an 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). In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated. In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

141

Start Date

2023-03-23

Completion Date

2025-06

Last Updated

2025-01-24

Healthy Volunteers

Yes

Conditions

Interventions

PROCEDURE

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.

OTHER

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.

OTHER

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).

Locations (1)

University Hospital of Basel (USB); Department of Anaesthesiology

Basel, Switzerland