Effects of Expectations on Hypoalgesia Produced by Mental Practice

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04621162
• Other study ID #: uammadrid100
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2020
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 30, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

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"
• 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"
• Neutral Expectations (initial)
This group will act as a control. No expectations will be given that will influence the participant.
• 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)
A negative expectation will be given during the performance of the mental practice. "This is working very bad"
• Neutral Expectations (during intervention)
This group will act as a control. No expectations will be given that will influence the participant.

Locations

Country	Name	City	State
Spain	CSEU La Salle	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid	Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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