Clinical trial NCT06408519: Open-Label Placebo for Non-Specific Pain in the ED
Official title: Open -Label Placebo for Non-specific Pain in the Emergency Department: Study Protocol for a Mixed-method Randomised Control Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Keywords: open-label placebo
non-specific pain
emergency department
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Roland Bingisser, Principal Investigator, Head of Emergency Department, University Hospital Basel
name: Jens Gaab, Co-investigator, Head of Division University of Basel, Faculty of Psychology
name: Bojana Degen, Co-investigator, University of Basel, Faculty of Psychology
name: Anna Szczesna, Co-investigator, University Hospital Basel, Emergency Department
name: Christian H Nickel, Co-investigator, Deputy Head of Emergency Department, University Hospital Basel
First posted: 2024-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mixed-method randomised control feasibility study
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of eligible patients consenting to participate
timeFrame: 12 months
measure: Rate of patients adhering to the study protocol in terms of medication intake
timeFrame: 7 days
measure: Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)
timeFrame: 30 days
measure: Rate of patients' satisfaction with the intervention and study procedure
timeFrame: 30 days
Secondary outcomes:
measure: Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: 8 days
measure: Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: 8 days
measure: Use of rescue medication
timeFrame: 8 days
measure: Frequency and nature of side effects, adverse events
timeFrame: 30 days
measure: Rate of patients with ED re-attendance
timeFrame: 30 days
measure: Average pain intensity 30 days after the ED index visit
timeFrame: 30 days
measure: Average pain interference 30 days after the ED index visit
timeFrame: 30 days
measure: Frequency of medication use between day 8 and 30
timeFrame: 30 days
measure: Rate of patients with specific cause of pain within 30 days of the index visit
timeFrame: 30 days
measure: Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints.
timeFrame: 30 days
Other outcomes:
measure: Rate of eligible patients declining consent
timeFrame: 1 day
measure: Expectancy of Pain Relief Scale on the day of index visit
timeFrame: 1 day
measure: Desire for Pain Relief Scale on the day of index visit
timeFrame: 1 day
measure: Placebo understanding during day of index visit
timeFrame: 1 day
measure: Placebo beliefs during day of index visit
timeFrame: 1 day
measure: Placebo intervention credibility during the index visit
timeFrame: 1 day
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Emergency Department, University Hospital Basel, Switzerland
name: Bruno Minotti, MD
role: STUDY_CHAIR
References: