Pain, Acute
Conditions
Keywords
open-label placebo, non-specific pain, emergency department
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.
Interventions
OTHERPlacebo (open-label)
P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day
DRUGIbuprofen 400 mg
Ibuprofen pills 3x/day
Sponsors
Bruno Minotti
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
mixed-method randomised control feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of eligible patients consenting to participate | 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 | 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) | 30 days | Feasibility Outcome. Threshold: ≥80% of patients with completed assessments/questionnaires.. |
| Rate of patients' satisfaction with the intervention and study procedure | 30 days | Feasibility Outcome. Threshold: ≥70% of patients with a score ≥6 on a scale from 0 (absolutely not satisfied) to 10 (absolutely satisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF) | 8 days | 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). |
| Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF) | 8 days | 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). |
| Use of rescue medication | 8 days | Clinical Outcome (exploratory). Proportion of patients requiring rescue medication (including amount of rescue medication intake) in both arms during the first 8 days. |
| Frequency and nature of side effects, adverse events | 30 days | Clinical Outcome (exploratory) |
| Rate of patients with ED re-attendance | 30 days | Clinical Outcome (exploratory) |
| Average pain intensity 30 days after the ED index visit | 30 days | 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). |
| Average pain interference 30 days after the ED index visit | 30 days | 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). |
| Frequency of medication use between day 8 and 30 | 30 days | Clinical Outcome (exploratory). Frequency of (optional) medication use between day 8 and 30. |
| Rate of patients with specific cause of pain within 30 days of the index visit | 30 days | 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). |
| Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints. | 30 days | Clinical Outcome (exploratory). PHQ-9 score from 0 (no depression) to 27 (severe depression). |
Countries
Switzerland
Contacts
STUDY_CHAIRBruno Minotti, MD
Emergency Department, University Hospital Basel, Switzerland
Outcome results
None listed