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

NCT06408519 | Completed

• 1 other identifier: 2024-00089; am24Bingisser
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Keywords

open-label placebo; non-specific pain; emergency department

Outcome Measures

Primary Outcomes (4)

• Rate of eligible patients consenting to participate

  Feasibility Outcome. Threshold: ≥30% of eligible patients for the target population of 50 patients within 12 months.

  12 months

• Rate of patients adhering to the study protocol in terms of medication intake

  Feasibility Outcome. Threshold: ≥70% of patients with at least ≥70% medication intake according to the protocol.

  7 days

• Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)

  Feasibility Outcome. Threshold: ≥80% of patients with completed assessments/questionnaires..

  30 days

• Rate of patients' satisfaction with the intervention and study procedure

  Feasibility Outcome. Threshold: ≥70% of patients with a score ≥6 on a scale from 0 (absolutely not satisfied) to 10 (absolutely satisfied).

  30 days

Secondary Outcomes (10)

• Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)

  8 days

• Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)

  8 days

• Use of rescue medication

  8 days

• Frequency and nature of side effects, adverse events

  30 days

• Rate of patients with ED re-attendance

  30 days

Other Outcomes (6)

• Rate of eligible patients declining consent

  1 day

• Expectancy of Pain Relief Scale on the day of index visit

  1 day

• Desire for Pain Relief Scale on the day of index visit

  1 day

Study Arms (2)

Open-label Placebo

EXPERIMENTAL

Treatment with open-label placebo pills 3x/day

Other: Placebo (open-label)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual defined as Ibuprofen 3x/day

Drug: Ibuprofen 400 mg

Interventions

Placebo (open-label) OTHER

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

Open-label Placebo

Ibuprofen 400 mg DRUG

Ibuprofen pills 3x/day

Also known as: Ibuprofen-Sandoz

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bojana Degen, Co-investigator, University of Basel, Faculty of Psychology: collaborator
• Bruno Minotti: lead
• Roland Bingisser, Principal Investigator, Head of Emergency Department, University Hospital Basel: collaborator
• Jens Gaab, Co-investigator, Head of Division University of Basel, Faculty of Psychology: collaborator
• Anna Szczesna, Co-investigator, University Hospital Basel, Emergency Department: collaborator
• Christian H Nickel, Co-investigator, Deputy Head of Emergency Department, University Hospital Basel: collaborator

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40132833 DERIVED

MeSH Terms

Conditions

Acute Pain; Emergencies

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Bruno Minotti, MD

  Emergency Department, University Hospital Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator, University Hospital Basel, Emergency Department

Model Details: mixed-method randomised control feasibility study

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 10, 2024
• Study Start: May 23, 2024
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)