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Completed

NCT Number: NCT06408519

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Disease Attributes Emergencies Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo (open-label)

Other

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

Ibuprofen 400 mg

Drug

Ibuprofen pills 3x/day

Other names: Ibuprofen-Sandoz

Primary outcomes

  1. Rate of eligible patients consenting to participate

    Time frame: 12 months

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

  2. Rate of patients adhering to the study protocol in terms of medication intake

    Time frame: 7 days

    Feasibility Outcome. Threshold: ≥70% of patients with at least ≥70% medication intake according to the protocol.

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

    Time frame: 30 days

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

  4. Rate of patients' satisfaction with the intervention and study procedure

    Time frame: 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 outcomes

  1. Change in pain intensity as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 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).

  2. Change in pain interference as measured through daily self-reported Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 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).

  3. Use of rescue medication

    Time frame: 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.

  4. Frequency and nature of side effects, adverse events

    Time frame: 30 days

    Clinical Outcome (exploratory)

  5. Rate of patients with ED re-attendance

    Time frame: 30 days

    Clinical Outcome (exploratory)

  6. Average pain intensity 30 days after the ED index visit

    Time frame: 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).

  7. Average pain interference 30 days after the ED index visit

    Time frame: 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).

  8. Frequency of medication use between day 8 and 30

    Time frame: 30 days

    Clinical Outcome (exploratory). Frequency of (optional) medication use between day 8 and 30.

  9. Rate of patients with specific cause of pain within 30 days of the index visit

    Time frame: 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).

  10. Depression measured by depression scale of the German version of the Patient Health Questionnaire (PHQ-9) at different timepoints.

    Time frame: 30 days

    Clinical Outcome (exploratory). PHQ-9 score from 0 (no depression) to 27 (severe depression).

Other outcomes

  1. Rate of eligible patients declining consent

    Time frame: 1 day

    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.

  2. Expectancy of Pain Relief Scale on the day of index visit

    Time frame: 1 day

    Additional variables of interests. Score from 0 (no expectancy of pain relief) to 10 (maximum expectancy of pain relief).

  3. Desire for Pain Relief Scale on the day of index visit

    Time frame: 1 day

    Additional variables of interests. Score from 0 (no desire of pain relief) to 10 (maximum desire of pain relief).

  4. Placebo understanding during day of index visit

    Time frame: 1 day

    Additional variables of interests. Qualitative analysis (open questions) on placebo understanding.

  5. Placebo beliefs during day of index visit

    Time frame: 1 day

    Additional variables of interests. Qualitative analysis (open questions) on placebo beliefs.

  6. Placebo intervention credibility during the index visit

    Time frame: 1 day

    Additional variables of interests. Qualitative analysis (open questions) on placebo credibility.

Sponsors and collaborators

Lead sponsor

Bruno Minotti

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: OLP_EM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 10, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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