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

Pain, Acute Clinical Trial

— OLP_EM  

Official title:

Open -Label Placebo for Non-specific Pain in the Emergency Department: Study Protocol for a Mixed-method Randomised Control Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06408519
• Other study ID #: 2024-00089; am24Bingisser
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Bruno Minotti, MD
• Phone: +41615565324
• Email: bruno.minotti[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Other:
• Placebo (open-label)
P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day

Drug:
• Ibuprofen 400 mg
Ibuprofen pills 3x/day

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (6)

Lead Sponsor

Collaborator

Bruno Minotti

Anna Szczesna, Co-investigator, University Hospital Basel, Emergency Department, Bojana Degen, Co-investigator, University of Basel, Faculty of Psychology, Christian H Nickel, Co-investigator, Deputy Head of Emergency Department, University Hospital Basel, Jens Gaab, Co-investigator, Head of Division University of Basel, Faculty of Psychology, Roland Bingisser, Principal Investigator, Head of Emergency Department, University Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of eligible patients declining consent	Additional variables of interests. If communicated (NOTE: not mandatory according to Good Clinical Practice), the reason for declining will also be recorded for anonymous qualitative analysis.	1 day
Other	Expectancy of Pain Relief Scale on the day of index visit	Additional variables of interests. Score from 0 (no expectancy of pain relief) to 10 (maximum expectancy of pain relief).	1 day
Other	Desire for Pain Relief Scale on the day of index visit	Additional variables of interests. Score from 0 (no desire of pain relief) to 10 (maximum desire of pain relief).	1 day
Other	Placebo understanding during day of index visit	Additional variables of interests. Qualitative analysis (open questions) on placebo understanding.	1 day
Other	Placebo beliefs during day of index visit	Additional variables of interests. Qualitative analysis (open questions) on placebo beliefs.	1 day
Other	Placebo intervention credibility during the index visit	Additional variables of interests. Qualitative analysis (open questions) on placebo credibility.	1 day
Primary	Rate of eligible patients consenting to participate	Feasibility Outcome. Threshold: =30% of eligible patients for the target population of 50 patients within 12 months.	12 months
Primary	Rate of patients adhering to the study protocol in terms of medication intake	Feasibility Outcome. Threshold: =70% of patients with at least =70% medication intake according to the protocol.	7 days
Primary	Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)	Feasibility Outcome. Threshold: =80% of patients with completed assessments/questionnaires..	30 days
Primary	Rate of patients' satisfaction with the intervention and study procedure	Feasibility Outcome. Threshold: =70% of patients with a score =6 on a scale from 0 (absolutely not satisfied) to 10 (absolutely satisfied).	30 days
Secondary	Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)	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).	8 days
Secondary	Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)	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).	8 days
Secondary	Use of rescue medication	Clinical Outcome (exploratory). Proportion of patients requiring rescue medication (including amount of rescue medication intake) in both arms during the first 8 days.	8 days
Secondary	Frequency and nature of side effects, adverse events	Clinical Outcome (exploratory)	30 days
Secondary	Rate of patients with ED re-attendance	Clinical Outcome (exploratory)	30 days
Secondary	Average pain intensity 30 days after the ED index visit	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).	30 days
Secondary	Average pain interference 30 days after the ED index visit	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).	30 days
Secondary	Frequency of medication use between day 8 and 30	Clinical Outcome (exploratory). Frequency of (optional) medication use between day 8 and 30.	30 days
Secondary	Rate of patients with specific cause of pain within 30 days of the index visit	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).	30 days
Secondary	Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints.	Clinical Outcome (exploratory). PHQ-9 score from 0 (no depression) to 27 (severe depression).	30 days