Pain, AcuteOLP_EMNCT06408519
Open-Label Placebo for Non-Specific Pain in the ED
A study testing Ibuprofen 400 mg in people with Pain, Acute, run by Bruno Minotti at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 May 2024to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Acute
- Being tested
- Placebo (open-label), Ibuprofen 400 mg
- Keywords
- open-label placebo, non-specific pain, emergency department
- Medical subject headings
- Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (open-label)Other
P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day
Ibuprofen 400 mgDrug
Also called Ibuprofen-Sandoz
Ibuprofen pills 3x/day
| Study group | Role | What they receive |
|---|---|---|
| Open-label Placebo | Experimental | Treatment with open-label placebo pills 3x/day Receives: Other: Placebo (open-label) |
| Treatment as usual | Active comparator | Treatment as usual defined as Ibuprofen 3x/day Receives: Drug: Ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of eligible patients consenting to participate
Feasibility Outcome. Threshold: ≥30% of eligible patients for the target population of 50 patients within 12 months.
Measured: 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.
Measured: 7 days
Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)
Feasibility Outcome. Threshold: ≥80% of patients with completed assessments/questionnaires..
Measured: 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).
Measured: 30 days
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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.
Measured: 8 days
Frequency and nature of side effects, adverse events
Clinical Outcome (exploratory)
Measured: 30 days
Rate of patients with ED re-attendance
Clinical Outcome (exploratory)
Measured: 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).
Measured: 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).
Measured: 30 days
Frequency of medication use between day 8 and 30
Clinical Outcome (exploratory). Frequency of (optional) medication use between day 8 and 30.
Measured: 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).
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start23 May 2024
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- mixed-method randomised control feasibility study
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruno Minotti
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Bruno Minotti, University Hospital, Basel, Switzerland
- Investigators
- Bruno Minotti, MD, Study chair, Emergency Department, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408519
- Sponsor's protocol ID
- 2024-00089; am24Bingisser
- Acronym
- OLP_EM
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40132833
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open -Label Placebo for Non-specific Pain in the Emergency Department: Study Protocol for a Mixed-method Randomised Control Feasibility Study
- ClinicalTrials.gov ID
- NCT06408519
- Acronym / sponsor ID
- OLP_EM / 2024-00089; am24Bingisser
- Conditions
- Pain, Acute
- Keywords
- open-label placebo, non-specific pain, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Bruno MinottiUniversity, hospital or other
- 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
- Study start
- 23 May 2024 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- mixed-method randomised control feasibility study
| Arm | Type | Receives |
|---|---|---|
| Open-label Placebo | Experimental | Other: Placebo (open-label)Treatment with open-label placebo pills 3x/day |
| Treatment as usual | Active comparator | Drug: Ibuprofen 400 mgTreatment as usual defined as Ibuprofen 3x/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (open-label)P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day | Other | Open-label Placebo |
| Ibuprofen 400 mgAlso: Ibuprofen-SandozIbuprofen pills 3x/day | Drug | Treatment as usual |
Primary outcome
Rate of eligible patients consenting to participate
Time frame: 12 months
Feasibility Outcome. Threshold: ≥30% of eligible patients for the target population of 50 patients within 12 months.
Rate of patients adhering to the study protocol in terms of medication intake
Time frame: 7 days
Feasibility Outcome. Threshold: ≥70% of patients with at least ≥70% medication intake according to the protocol.
Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)
Time frame: 30 days
Feasibility Outcome. Threshold: ≥80% of patients with completed assessments/questionnaires..
Rate of patients' satisfaction with the intervention and study procedure
Time frame: 30 days
Feasibility Outcome. Threshold: ≥70% of patients with a score ≥6 on a scale from 0 (absolutely not satisfied) to 10 (absolutely satisfied).
10 secondary outcomes
Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)
Time frame: 8 days
Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)
Time frame: 8 days
Use of rescue medication
Time frame: 8 days
Frequency and nature of side effects, adverse events
Time frame: 30 days
Rate of patients with ED re-attendance
Time frame: 30 days
Average pain intensity 30 days after the ED index visit
Time frame: 30 days
Average pain interference 30 days after the ED index visit
Time frame: 30 days
Frequency of medication use between day 8 and 30
Time frame: 30 days
Rate of patients with specific cause of pain within 30 days of the index visit
Time frame: 30 days
Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Derived from this study: PubMed 40132833Degen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Minotti, MD study chair
Emergency Department, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen 400 mg in people with Pain, Acute, run by Bruno Minotti at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of eligible patients consenting to participate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06408519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.