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Placebo EffectNCT02578420

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

A study of Placebo Effect and Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Placebo Effect, Pain, Expectancy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteSwitzerland
Study dates
Jan 2016to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Basel

    Basel, 4055

Other trials in Switzerland

About this study

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.

Read the detailed description

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

  1. 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;
  2. 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.

Being tested
open-label placebo, deceptive placebo
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open-label placeboOther

    Placebo Cream, openly described as "Placebo"

  • deceptive placeboOther

    Placebo Cream, described as "Voltaren, containing Diclofenac"

Study groups in NCT02578420
Study groupRoleWhat they receive
open-label placeboPlacebo comparatorParticipants (N=40) will have the information that they are receiving an inert cream (i.e. "placebo"). Placebo will be described as an inert or inactive cream, with no medication in it. Additionally, participants will be told that "placebo has been shown in rigorous clinical testing to produce significant mind-body self-healing processes." The placebo administration will be combined with the following scientific rationale/verbal suggestion: (a) placebos are effective analgesics, (b) classical conditioning as a possible mechanism of this effect, (c) compliance is important for outcome and (d) positive expectations increase placebo effects, but are not necessary.
Receives: Other: open-label placebo
deceptive placeboSham comparatorParticipants (N=40) will have the information that they are receiving an analgesic cream ("Antidolor, containing "Lidocain"), while in fact they will receive an inert cream, only. Antidolor will be described as an analgesic cream.
Receives: Other: deceptive placebo
control groupPlacebo comparatorParticipants (N=40) will have the information that they are receiving an inert control cream.
Receives: Other: open-label placebo
no treatment groupNo interventionParticipants (N=40) will be told that they are in the "no treatment group" and that they will not receive an analgesic cream.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. subjective intensity and unpleasantness ratings of heat pain tolerance

    Visual Analogue Scale (VAS)

    Measured: 2 hours

  2. objective heat pain tolerance

    Temperatures

    Measured: 2 hours

Secondary outcomes (12)

  1. Expectancy of Relief Scale (ERS; Erwartungsfragebogen)

    Measured: 2 hours

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

    Measured: 2 hours

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

    Measured: 2 hours

  4. sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD))

    Measured: 2 hours

  5. Revised Life Orientation Test (LOT-R)

    Measured: 2 hours

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

    Measured: 2 hours

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

    Measured: 2 hours

  8. Anxiety and Depression Scale (HADS-D)

    Measured: 2 hours

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

    Measured: 2 hours

  10. Desire for Relief Scale (DRS)

    Measured: 2 hours

  11. subjective intensity and unpleasantness ratings of heat pain threshold

    Visual Analogue Scale (VAS)

    Measured: 2 hours

  12. objective heat pain threshold

    Temperatures

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJul 2016
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02578420
Sponsor's protocol ID
EKNZ 2015-246
Status last verified
Jul 2017
First submitted
12 Oct 2015
Last updated
26 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Locher C, Buergler S, Frey Nascimento A, Kost L, Blease C, Gaab J. Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial. BMJ Open. 2021 Aug 18;11(8):e053346. doi: 10.1136/bmjopen-2021-053346.

    PubMed 34408060

Questions about this trial

What is this clinical trial studying?

A study of Placebo Effect and Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

subjective intensity and unpleasantness ratings of heat pain tolerance (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02578420, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.

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