Open-Label Placebo for Non-Specific Pain in the ED (OLP_EM)

Open -Label Placebo for Non-specific Pain in the Emergency Department: Study Protocol for a Mixed-method Randomised Control Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Other: Placebo (open-label); Drug: Ibuprofen 400 mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label Placebo; Treatment with open-label placebo pills 3x/day	Other: Placebo (open-label); P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day
Active Comparator: Treatment as usual; Treatment as usual defined as Ibuprofen 3x/day	Drug: Ibuprofen 400 mg; Ibuprofen pills 3x/day; Other Names: Ibuprofen-Sandoz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)	Clinical Outcome (exploratory). Score from 0 (no pain) to 10 (worste pain ever) for each pain severity subscale of the BPI-SF (minimal, average, and maximal pain intensity in the last 24 hours).	8 days
Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)	Clinical Outcome (exploratory). Score from 0 (no impact of pain) to 10 (maximal impact of pain) for each pain interference subscale of the BPI-SF (impact of pain in the last 24 hours on mood, sleep, activity, work, social relationships, enjoyment of life).	8 days
Use of rescue medication	Clinical Outcome (exploratory). Proportion of patients requiring rescue medication (including amount of rescue medication intake) in both arms during the first 8 days.	8 days
Frequency and nature of side effects, adverse events	Clinical Outcome (exploratory)	30 days
Rate of patients with ED re-attendance	Clinical Outcome (exploratory)	30 days
Average pain intensity 30 days after the ED index visit	Clinical Outcome (exploratory). Measured with a score from 0 (no pain) to 10 (worste pain ever) for each pain severity subscale of the BPI-SF (minimal, average, and maximal pain in the last 24 hours).	30 days
Average pain interference 30 days after the ED index visit	Clinical Outcome (exploratory). Measured with a score from 0 (no impact) to 10 (maximal impact) for each pain interference subscale of the BPI-SF (impact of pain in the last 24 hours on mood, sleep, activity, work, social relationships, enjoyment of life).	30 days
Frequency of medication use between day 8 and 30	Clinical Outcome (exploratory). Frequency of (optional) medication use between day 8 and 30.	30 days
Rate of patients with specific cause of pain within 30 days of the index visit	Clinical Outcome (exploratory). Rate and type of diagnosis of a specific cause of pain following the index visit (i.e. in the course, e.g. appendicitis diagnosed after presenting with "non-specific abdominal pain" at the index visit).	30 days
Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints.	Clinical Outcome (exploratory). PHQ-9 score from 0 (no depression) to 27 (severe depression).	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of eligible patients declining consent	Additional variables of interests. If communicated (NOTE: not mandatory according to Good Clinical Practice), the reason for declining will also be recorded for anonymous qualitative analysis.	1 day
Expectancy of Pain Relief Scale on the day of index visit	Additional variables of interests. Score from 0 (no expectancy of pain relief) to 10 (maximum expectancy of pain relief).	1 day
Desire for Pain Relief Scale on the day of index visit	Additional variables of interests. Score from 0 (no desire of pain relief) to 10 (maximum desire of pain relief).	1 day
Placebo understanding during day of index visit	Additional variables of interests. Qualitative analysis (open questions) on placebo understanding.	1 day
Placebo beliefs during day of index visit	Additional variables of interests. Qualitative analysis (open questions) on placebo beliefs.	1 day
Placebo intervention credibility during the index visit	Additional variables of interests. Qualitative analysis (open questions) on placebo credibility.	1 day

Collaborators and Investigators

• Sponsor: Bruno Minotti
• Collaborators: Roland Bingisser, Principal Investigator, Head of Emergency Department, University Hospital Basel; Jens Gaab, Co-investigator, Head of Division University of Basel, Faculty of Psychology; Bojana Degen, Co-investigator, University of Basel, Faculty of Psychology; Anna Szczesna, Co-investigator, University Hospital Basel, Emergency Department; Christian H Nickel, Co-investigator, Deputy Head of Emergency Department, University Hospital Basel
• Investigators: Study Chair: Bruno Minotti, MD, Emergency Department, University Hospital Basel, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Actual): February 13, 2026
• Study Completion (Actual): February 13, 2026

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: emergency department; open-label placebo; non-specific pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergencies; Acute Pain; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Phenylpropionates; Ibuprofen
• Other Study ID Numbers: 2024-00089; am24Bingisser

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No