Open-Label Placebo for Non-Specific Pain in the ED

NCT ID: NCT06408519

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2026-05-31

Brief Summary

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The aim of this study is to assess whether an intervention with open-label placebo (OLP) for non-specific pain in the emergency department is feasible.

Detailed Description

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This project is a collaboration between the Emergency Department at the University Hospital of Basel and the Faculty of Psychology at the University of Basel. The investigation will analyze whether an intervention consisting of open-label placebo tablets is feasible for patients with non-specific pain in the emergency department. Open-label placebos are administered without deception, meaning the patients are aware they are taking a placebo. Patients will be randomized into intervention group (OLP) or control group (treatment as usual) with ibuprofen. The study duration for patients is 30 days.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

mixed-method randomised control feasibility study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Open-label Placebo

Treatment with open-label placebo pills 3x/day

Group Type EXPERIMENTAL

Placebo (open-label)

Intervention Type OTHER

P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day

Treatment as usual

Treatment as usual defined as Ibuprofen 3x/day

Group Type ACTIVE_COMPARATOR

Ibuprofen 400 mg

Intervention Type DRUG

Ibuprofen pills 3x/day

Interventions

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Placebo (open-label)

P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day

Intervention Type OTHER

Ibuprofen 400 mg

Ibuprofen pills 3x/day

Intervention Type DRUG

Other Intervention Names

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Ibuprofen-Sandoz

Eligibility Criteria

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Inclusion Criteria

* Established diagnosis of non-specific acute pain
* Able to understand the study and its outcome measures
* Signed informed consent
* 18 years or older
* Sufficient German language skills

Exclusion Criteria

* Chronic pain
* Treatment with pain medication for \> 7 days prior to ED visit
* Known allergy or intolerance to ibuprofen
* Known hereditary galactose-intolerance, lactase deficiency or glucosegalactose malabsorption
* Participation in another clinical trial with medicinal products
* Need for hospitalization
* Known pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roland Bingisser, Principal Investigator, Head of Emergency Department, University Hospital Basel

UNKNOWN

Sponsor Role collaborator

Jens Gaab, Co-investigator, Head of Division University of Basel, Faculty of Psychology

UNKNOWN

Sponsor Role collaborator

Bojana Degen, Co-investigator, University of Basel, Faculty of Psychology

UNKNOWN

Sponsor Role collaborator

Anna Szczesna, Co-investigator, University Hospital Basel, Emergency Department

UNKNOWN

Sponsor Role collaborator

Christian H Nickel, Co-investigator, Deputy Head of Emergency Department, University Hospital Basel

UNKNOWN

Sponsor Role collaborator

Bruno Minotti

OTHER

Sponsor Role lead

Responsible Party

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Bruno Minotti

Sponsor Investigator, University Hospital Basel, Emergency Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bruno Minotti, MD

Role: STUDY_CHAIR

Emergency Department, University Hospital Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Bruno Minotti, MD

Role: CONTACT

+41615565324

References

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Degen B, Szczesna A, Nickel CH, Bingisser R, Gaab J, Minotti B. Open-label placebo for non-specific pain in the emergency department (OLP EM): study protocol for a mixed-method randomised control feasibility study in Switzerland. BMJ Open. 2025 Mar 25;15(3):e090508. doi: 10.1136/bmjopen-2024-090508.

Reference Type DERIVED
PMID: 40132833 (View on PubMed)

Other Identifiers

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2024-00089; am24Bingisser

Identifier Type: -

Identifier Source: org_study_id

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