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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02578420
Other study ID # EKNZ 2015-246
Secondary ID
Status Completed
Phase N/A
First received October 12, 2015
Last updated July 25, 2017
Start date January 2016
Est. completion date June 2017

Study information

Verified date July 2017
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 design, investigating their influence on placebo analgesia.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 2017
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
open-label placebo
Placebo Cream, openly described as "Placebo"
deceptive placebo
Placebo Cream, described as "Voltaren, containing Diclofenac"

Locations

Country Name City State
Switzerland University of Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary subjective intensity and unpleasantness ratings of heat pain tolerance Visual Analogue Scale (VAS) 2 hours
Primary objective heat pain tolerance Temperatures 2 hours
Secondary Expectancy of Relief Scale (ERS; Erwartungsfragebogen) 2 hours
Secondary Credibility and Effectiveness of the placebo analgesia expectation; adapted Version of the Context Model Questionnaire; Kontextmodellfragebogen (KMF) 2 hours
Secondary multidimensional sensitivities questionnaire (Mehrdimensionaler Befindlichkeitsfragebogen (MDBF)) 2 hours
Secondary sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD)) 2 hours
Secondary Revised Life Orientation Test (LOT-R) 2 hours
Secondary NEO five-factor inventory (NEO-FFI) 2 hours
Secondary questionnaire on competence and locus of control (Fragebogen zu Kompetenz- und Kontrollüberzeugungen (FKK)) 2 hours
Secondary Anxiety and Depression Scale (HADS-D) 2 hours
Secondary Beliefs in holistic health and holistic treatments; Complementary and Alternative Medicine Beliefs Intentory (CAMBI) 2 hours
Secondary Desire for Relief Scale (DRS) 2 hours
Secondary subjective intensity and unpleasantness ratings of heat pain threshold Visual Analogue Scale (VAS) 2 hours
Secondary objective heat pain threshold Temperatures 2 hours
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