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

Bruno Minotti

Status: Enrolling

Conditions: Pain, Acute

Treatments: Drug: Ibuprofen 400 mg; Other: Placebo (open-label)

Study type: Interventional

Funder types: Other

Identifiers

NCT06408519

2024-00089 am24Bingisser;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Open-label Placebo

Experimental group

Description:

Treatment with open-label placebo pills 3x/day

Treatment:

Other: Placebo (open-label)

Treatment as usual

Active Comparator group

Description:

Treatment as usual defined as Ibuprofen 3x/day

Treatment:

Drug: Ibuprofen 400 mg