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
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedStudy Start
First participant enrolled
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedNovember 9, 2020
November 1, 2020
6 months
November 3, 2020
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (6)
Positive Expectations (initial)
EXPERIMENTALNegative Expectations (initial)
EXPERIMENTALNeutral Expectations (initial)
PLACEBO COMPARATORPositive Expectations (during intervention)
EXPERIMENTALNegative Expectations (during intervention)
EXPERIMENTALNeutral Expectations (during intervention)
PLACEBO COMPARATORInterventions
A positive expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. "This task will generate hypoalgesia"
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"
This group will act as a control. No expectations will be given that will influence the participant.
A positive expectation will be given during the performance of the mental practice. "This is working very well"
A negative expectation will be given during the performance of the mental practice. "This is working very bad"
This group will act as a control. No expectations will be given that will influence the participant.
Eligibility Criteria
You may qualify if:
- Age between 18 and 60
- Healthy and with no pain subjects
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Autonoma de Madridlead
- Centro Universitario La Sallecollaborator
Study Sites (1)
CSEU La Salle
Madrid, 28023, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 3, 2020
First Posted
November 9, 2020
Study Start
December 30, 2020
Primary Completion
July 1, 2021
Study Completion
July 30, 2021
Last Updated
November 9, 2020
Record last verified: 2020-11