NCT03361579

Brief Summary

Open Label Placebo application has been shown to be effective in treatment of chronic pain (low back pain) and disease like the irritable bowel Syndrome. Data about effects on acute pain are spare. The study investigates the effect of an open-label Placebo (substance without a medical active component) application on acute pain, evoked via a artificial pain model in healthy male volunteers. 32 healthy male volunteers are recruited.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

November 17, 2017

Last Update Submit

May 15, 2018

Conditions

Acute Pain

Keywords

Placebo

Outcome Measures

Primary Outcomes (1)

  • Pain response measured by the Area under the Pain Curve (AUPC)

    Pain response measured by creating the Area under the Pain Curve (AUPC), using the numeric rating scale (NRS) from minute 30 to 100 during constant induced pain with electrical current at the forearm of the participant. Measuring of pain every 10 minutes from minute 30 to 100 (Minute 30,40,50,60,70,80,90, 100) in an experimental setting. Main comparison: The effect of open label placebo v.s. no treatment intervention

    30 minutes after baseline until 100 minutes after baseline

Secondary Outcomes (4)

  • Differences in pain response measured by the AUPC due to education

    30 minutes after baseline until 100 minutes after baseline

  • hyperalgesia

    100min

  • Saliva cortisol concentration in μg/dL

    baseline until 100 min after baseline

  • allodynia

    100minutes

Study Arms (2)

Placebo education group

OTHER

Prior to the intervention during the Placebo is given, the volunteer receives a detailed information about the effect and the strength of an open-label placebo. This education is performed via a slide show and a news report video. The important terms for Placebo analgesia: positive expectations, conditioning, communication are discussed

Other: Education

Placebo non education group

OTHER

No detailed Information about open-label placebo prior to the intervention. The volunteer is told about the possible strength of the Placebo effect on pain directly before the application.

Other: Education

Interventions

EducationOTHER

c.p. intervention description

Placebo education groupPlacebo non education group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male volunteers (American Society of Anaesthesiologist's Class I or II)
  • Body mass index between 18 and 25kg/m2
  • Able to understand the study and the NRS scale
  • Able to give informed consent

You may not qualify if:

  • Recreational drug abuse
  • Regularly taking medication potentially interfere with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers)
  • Neuropathy
  • Chronic pain
  • Neuromuscular or psychiatric disease
  • Known or suspected kidney or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Wilhelm Ruppen, PD

    Dep. Anesthesiology University Hospital Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator is blinded about the source of education a participant recieved prior to Placebo application. Investigator is blinded about during which Intervention the Placebo is applicated
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: investigator blinded, cross over design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

December 5, 2017

Study Start

November 11, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

CH(1)