Effects of Expectations on Hypoalgesia Produced by Mental Practice

Evaluation of the Influence of Cognitive Variables in Hypoalgesia Generated by Motor Imagery: A Randomized Controlled Trial

The main objective of this research work is to evaluate and quantify the hypoalgesia generated by motor imagery influenced by the presence of expectations.

Study Overview

• Status: Unknown
• Conditions: Cognitive Change
• Intervention / Treatment: Behavioral: Positive Expectations (initial); Behavioral: Negative Expectations (initial); Behavioral: Neutral Expectations (initial); Behavioral: Positive Expectations (during intervention); Behavioral: Experimental: Negative Expectations (during intervention); Behavioral: Neutral Expectations (during intervention)

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28023
    • CSEU La Salle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 60
• Healthy and with no pain subjects

Exclusion Criteria:

• Any cognitive impairment that hindered viewing of audiovisual material.
• Difficulty understanding or communicating.
• Presence of systemic pathology, Central Nervous System or rheumatic disease.
• Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
• Collaboration of pregnant women.
• Underage subjects
• Subjects with pain at the time of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Positive Expectations (initial)	Behavioral: Positive Expectations (initial); A positive expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. "This task will generate hypoalgesia"
EXPERIMENTAL: Negative Expectations (initial)	Behavioral: Negative Expectations (initial); A negative expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. "This task will not generate hypoalgesia"
PLACEBO_COMPARATOR: Neutral Expectations (initial)	Behavioral: Neutral Expectations (initial); This group will act as a control. No expectations will be given that will influence the participant.
EXPERIMENTAL: Positive Expectations (during intervention)	Behavioral: Positive Expectations (during intervention); A positive expectation will be given during the performance of the mental practice. "This is working very well"
EXPERIMENTAL: Negative Expectations (during intervention)	Behavioral: Experimental: Negative Expectations (during intervention); A negative expectation will be given during the performance of the mental practice. "This is working very bad"
PLACEBO_COMPARATOR: Neutral Expectations (during intervention)	Behavioral: Neutral Expectations (during intervention); This group will act as a control. No expectations will be given that will influence the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain pressure threshold	Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high.	Change from baseline and immediately post-intervention
Thermal threshold	This variable will evaluate three aspects. Cold detection threshold, heat detection threshold and heat pain threshold. A specialized and validated instrument is used which consists of a sensor with a resistance that raises and lowers the temperature in a controlled way between 20 and 50ºC.	Change from baseline and immediately post-intervention
Heart Rate	Heart Rate will be measured by three electrodes located in the left area of the chest. One of the electrodes is placed in the middle zone while a second electrode is positioned on the lateral side, and a third one on the lower left side, below the first electrode.	Change from baseline and immediately post-intervention

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Collaborators: Centro Universitario La Salle

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 30, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 30, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (ACTUAL): November 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Motor imagery
• Other Study ID Numbers: uammadrid100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No