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

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.

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.

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