NCT03484728

Brief Summary

The interaction between conditioned pain modulation and expectation in understanding the placebo effect of pain reduction

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 healthy

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

January 31, 2018

Last Update Submit

May 19, 2021

Conditions

Healthy

Keywords

Conditional pain modulationpainplacebo

Outcome Measures

Primary Outcomes (2)

  • Change in pain perception

    pain units on a scale of 0-100. 0 no pain. 100 = the maximum pain

    up to 2 weeks

  • Change in conditioned pain modulation (CPM)

    change in pain units on a scale of 0-100. 0 no pain. 100 = the maximum pain

    up to 2 weeks

Study Arms (2)

High-expectation placebo manipulation

PLACEBO COMPARATOR

application of nonactive body cream on forearm for 10 minutes

Behavioral: placebo manipulation

Low-expectation placebo manipulation

OTHER

application of nonactive body cream on forearm for 10 minutes

Behavioral: placebo manipulation

Interventions

placebo manipulationBEHAVIORAL

application of nonactive body cream on forearm

High-expectation placebo manipulationLow-expectation placebo manipulation

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • attention deficit.
  • pain disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical center, Neurology Department

Haifa, Israel

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The participants were told that the cream has poweful analgetic effect in one session; and that the cream has minmal analgesic effect in another session.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: CPM was tested before and after the placebo manipulation (body cream application on forearm); based on the expectation of the cream analgesic response (high or low), two types of placebo manipulations were performed for each participant.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

April 2, 2018

Study Start

March 27, 2018

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)