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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578420
• Other study ID #: EKNZ 2015-246
• 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
• 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.)

Related Conditions & MeSH terms

• Expectancy
• Pain
• Placebo Effect

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