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NCT Number: NCT02578420

Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel

Basel, 4055, Switzerland

About this study

The current project will consist of one experimental study and one qualitative study:

  • the effects of open-label, and deceptive placebo administration on placebo analgesia will be directly compared when both groups have a comparable expectancy-inducing scientific rationale;
  • subjective meaning models will be assessed by comparing subjective narratives of the placebo effect in open-label and deceptive placebo groups in a nested qualitative study.

The experimental study will be a randomized experiment with healthy subjects (N=120), and pain will be induced using a standardized heat pain paradigm (Medoc, Ramatishai, Israel; thermo-sensory analyzer (TSA)-II). Effects of the experimental conditions will be assessed both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective pain ratings, pain intensity and unpleasantness). Furthermore, investigators will randomly select 30 participants to take part in a nested qualitative study in order to qualitatively assess the meaning response by comparing subjective narratives of the placebo effect in the open-label and deceptive placebo groups, as well as in the control group.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female adults aged 18-65
  • Healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders
  • Right-handedness (Oldfield, 1971),
  • Willing to participate in study

Exclusion criteria

  • Medicine or Psychology Students
  • Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality
  • Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
  • Insufficient German language skills to understand the instructions
  • Previous participation in studies using pain assessment (threshold and tolerance) with Peltier Devices
  • Daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
  • Current or regular drug consumption (THC, cocaine, heroin, etc.)

Treatment and study plan

open-label placebo

Other

Placebo Cream, openly described as "Placebo"

deceptive placebo

Other

Placebo Cream, described as "Voltaren, containing Diclofenac"

Primary outcomes

  1. subjective intensity and unpleasantness ratings of heat pain tolerance

    Time frame: 2 hours

    Visual Analogue Scale (VAS)

  2. objective heat pain tolerance

    Time frame: 2 hours

    Temperatures

Secondary outcomes

  1. Expectancy of Relief Scale (ERS; Erwartungsfragebogen)

    Time frame: 2 hours

  2. Credibility and Effectiveness of the placebo analgesia expectation; adapted Version of the Context Model Questionnaire; Kontextmodellfragebogen (KMF)

    Time frame: 2 hours

  3. multidimensional sensitivities questionnaire (Mehrdimensionaler Befindlichkeitsfragebogen (MDBF))

    Time frame: 2 hours

  4. sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD))

    Time frame: 2 hours

  5. Revised Life Orientation Test (LOT-R)

    Time frame: 2 hours

  6. NEO five-factor inventory (NEO-FFI)

    Time frame: 2 hours

  7. questionnaire on competence and locus of control (Fragebogen zu Kompetenz- und Kontrollüberzeugungen (FKK))

    Time frame: 2 hours

  8. Anxiety and Depression Scale (HADS-D)

    Time frame: 2 hours

  9. Beliefs in holistic health and holistic treatments; Complementary and Alternative Medicine Beliefs Intentory (CAMBI)

    Time frame: 2 hours

  10. Desire for Relief Scale (DRS)

    Time frame: 2 hours

  11. subjective intensity and unpleasantness ratings of heat pain threshold

    Time frame: 2 hours

    Visual Analogue Scale (VAS)

  12. objective heat pain threshold

    Time frame: 2 hours

    Temperatures

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 19, 2015
Registry last updated
Jul 26, 2017

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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