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

Bruno Minotti57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pain, Acute

Interventions

Placebo (open-label)OTHER

P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day

Ibuprofen 400 mgDRUG

Ibuprofen pills 3x/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Rate of eligible patients consenting to participate

Feasibility Outcome. Threshold: ≥30% of eligible patients for the target population of 50 patients within 12 months.

Time frame: 12 months

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.

Time frame: 7 days

Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)

Feasibility Outcome. Threshold: ≥80% of patients with completed assessments/questionnaires..

Time frame: 30 days

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).

Time frame: 30 days

Secondary Outcomes

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).

Time frame: 8 days

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).

Data from ClinicalTrials.gov

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