NCT05819476 Boosting Open-Label Placebo Effects in Acute Induced Pain in Healthy Adults
| NCT ID | NCT05819476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Acute Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 141 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 141 participants in total. It began in 2023-03-23 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Healthy volunteers (ASA Class I or II), aged 18 to 65 years * BMI between 18 and 25kg/m2 * Able to understand the study and the NRS * Able to give informed consent Exclusion Criteria: * Participation in a previous open-label placebo study; for Part 2, this includes Part 1 of this study * Regular intake of medications or drugs potentially interfering with pain sensation (analgesics, opioids, antihistamines, calcium and potassium channel blockers, serotonin/ noradrenaline reuptake inhibitors, corticosteroids) * Neuropathy * Chronic pain * Neuromuscular disease * Dermatological disease (i.e. Atopic Dermatitis) * Psychiatric disease * Pregnancy / Lactation
Contact & Investigator
Tobias Schneider, MD
PRINCIPAL INVESTIGATOR
Department of Anaesthesiology, University Hospital of Basel (USB)
Frequently Asked Questions
Who can join the NCT05819476 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05819476 currently recruiting?
Yes, NCT05819476 is actively recruiting participants. Contact the research team at tobias.schneider@usb.ch for enrollment information.
Where is the NCT05819476 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT05819476 clinical trial?
NCT05819476 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Tobias Schneider, MD at Department of Anaesthesiology, University Hospital of Basel (USB). The trial plans to enroll 141 participants.