What is this study trying to find out about acute pain?

This study is evaluating how open-label placebo injections affect acute pain using a controlled electrical stimulation model. Researchers want to understand the timing, size, and duration of pain relief when placebos are given openly without deception. The research is led by University Hospital, Basel, Switzerland, to explore new pain management options.

Who may be eligible for this acute pain clinical trial?

Adults aged 18 to 65 years who are healthy volunteers may be eligible. Participants should not have chronic pain, neuropathy, psychiatric or neuromuscular diseases, and must not be pregnant or breastfeeding. Regular use of certain pain-related medications excludes participation. Please review eligibility criteria for more details.

Is there any cost to participate in this acute pain clinical trial?

Study-related care, including the placebo injections and all trial visits, is provided at no cost. However, personal travel costs and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID05819476

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

Led by University Hospital, Basel, Switzerland · Updated on 2025-01-24

141

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the effects of open-label placebo (OLP) injections on acute pain using a controlled experimental model that simulates wound pain with electrical pulses. This randomized crossover study aims to understand how OLP affects pain intensity, the duration of analgesia, and differences in outcomes when injections are given once, repeated at fixed times, or repeated on demand. The study includes healthy adult volunteers aged 18 to 65 years. Participants will undergo an experimental pain procedure where electrical stimulation is adjusted to cause moderate pain, rated 6 out of 10 on a numeric scale. In Part 1, participants receive one OLP injection after 20 minutes during one visit, with a no-treatment visit serving as control. In Part 2, participants are divided into groups receiving a single injection, two injections at fixed times, or two injections with the second given on demand. Each injection contains saline without active ingredients and is accompanied by an explanation about placebo effects. During the study, participants' pain ratings and areas of pain sensitivity (hyperalgesia and allodynia) are measured repeatedly for up to 200 minutes after stimulation. Researchers track changes in pain over three hours after each OLP injection. The study monitors safety and collects subjective and objective pain data to evaluate the timing, effect size, and duration of OLP analgesia. Total participation includes multiple visits with randomized treatment order and follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Healthy volunteers classified as ASA Class I or II, aged 18 to 65 years
Body mass index (BMI) between 18 and 25 kg/m2
Able to understand the study and numeric rating scale (NRS)
Able to give informed consent

You will not qualify if you...

Participation in a previous open-label placebo study, including Part 1 for Part 2 participants
Regular use of medications affecting pain sensation (analgesics, opioids, antihistamines, calcium and potassium channel blockers, serotonin/noradrenaline reuptake inhibitors, corticosteroids)
Presence of neuropathy
Chronic pain conditions
Neuromuscular diseases
Dermatological diseases such as atopic dermatitis
Psychiatric diseases
Pregnancy or lactation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Experimental Pain Model and Open-Label Placebo Intervention

Duration - Up to 3 hours per visit

Participants undergo an experimental acute pain model involving electrical stimulation and receive open-label placebo injections with an evidence-based treatment rationale. In Part 1, participants experience two visits in a crossover design, receiving either the placebo injection or no treatment in each visit. In Part 2, participants receive one or two placebo injections depending on their group, with booster injections given either at a fixed time or on demand.

2 visits in Part 1; 1 to 2 visits in Part 2 depending on group

Trial Site Locations

Total: 1 location

University Hospital of Basel (USB); Department of Anaesthesiology

Basel, Switzerland, 4031

Actively Recruiting

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Research Team

Tobias Schneider, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

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