Open-Label Placebo for Non-Specific Pain in the ED
- Conditions
- Pain, Acute
- Interventions
- Other: Placebo (open-label)
- Registration Number
- NCT06408519
- Lead Sponsor
- Bruno Minotti
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open-label Placebo Placebo (open-label) Treatment with open-label placebo pills 3x/day Treatment as usual Ibuprofen 400 mg Treatment as usual defined as Ibuprofen 3x/day
- Primary Outcome Measures
Name Time Method 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 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' 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
University Hospital Basel
🇨🇭Basel, Switzerland