- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03959449
Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects
July 19, 2019 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid
This study evaluates the influence of motor imagery and the observation of actions on pain perception.
Participants in this study are asymptomatic subjects who will perform an IM and AO protocol of an aerobic exercise.
Study Overview
Status
Completed
Detailed Description
Motor Imagery (MI) is defined as a dynamic mental process that involves the representation of an action, in an internal way, without its actual motor execution.
The Action Observation (AO) evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually.
Both mental processes trigger the activation of the neurocognitive mechanisms that underlie the planning and execution of voluntary movements in a manner that resembles how the action is performed in a real manner.
The phenomenon of exercise-induced hypoalgesia is well known.
This is why it has been suggested that these techniques could produce pain modulation similar to that produced by real exercise.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28023
- CSEU La Salle
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Action Observation and Motor imagery
|
Action observation (video) and motor imagery of running.
|
Active Comparator: Motor Imagery
|
Motor imagery of running
|
Experimental: Exercise plus motor imagery and action observation
|
Real exercise of running during 6 min plus action observation (video) and motor imagery of running.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain pressure threshold
Time Frame: Change from baseline and immediately post-intervention
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electrodermal Activity
Time Frame: Change in electrodermal activity after 5 minutes post-intervention
|
Electrodermal Activity will be measured through the use of two electrodes that recorded changes in conductance through the skin located at the back of the dominant hand
|
Change in electrodermal activity after 5 minutes post-intervention
|
Visual and Kinesthetic Motor Imagery Ability
Time Frame: Immediately before the intervention
|
Visual and Kinesthetic Motor Imagery Ability will be measured with Movement Imagery Questionnaire-Revised (MIQ-R).
MIQ-R has four movements repeated in two subscales, a visual and a kinesthetic one.
Additionally, a score between 1 and 7 is assigned, with 1 representing difficulty in picturing the motor image or difficulty in feeling the movement previously made, and 7 representing the maximum ease.
The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale (Campos & González, 2010).
|
Immediately before the intervention
|
The degree of physical activity
Time Frame: Immediately before the intervention
|
The degree of physical activity was objectified through the The International Physical Activity Questionnaire (IPAQ) questionnaire, which allows the subjects to be divided into three groups according to their level of activity, which can be high, moderate, and low or inactive.
The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) performed in the last seven days, as well as walking and sitting time on a workday.
The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively.
|
Immediately before the intervention
|
Kinesiophobia
Time Frame: Immediately before the intervention
|
Fear of movement or kinesiophobia will be quantified with the Spanish version of the Kinesiophobia Tampa Scale (TSK-11).
This instrument demonstrates reliability and validity in patients with chronic pain, being shorter than the original scale.
The total score ranges from 11 to 44 points, with the highest scores indicating greater fear of a new injury due to movement
|
Immediately before the intervention
|
Respiration Rate
Time Frame: Change in electrodermal activity after 5 minutes post-intervention
|
Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap
|
Change in electrodermal activity after 5 minutes post-intervention
|
Respiration Rate
Time Frame: Change in electrodermal activity after 5 minutes post-intervention
|
Heart Rate will be measured by three electrodes located in the left area of the chest.
One of the electrodes was placed in the middle zone while a second electrode was positioned on the lateral side, and a third one on the lower left side, below the first electrode.
|
Change in electrodermal activity after 5 minutes post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2019
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
July 15, 2019
Study Registration Dates
First Submitted
May 20, 2019
First Submitted That Met QC Criteria
May 20, 2019
First Posted (Actual)
May 22, 2019
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 19, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- uammadrid8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Analgesia
-
Mansoura UniversityNot yet recruiting
-
Southeast University, ChinaRecruiting
-
Medical University of South CarolinaRecruiting
-
Southeast University, ChinaRecruiting
-
Huazhong University of Science and TechnologyRecruiting
-
Mansoura UniversityCompleted
-
University of FloridaMdoloris Medical SystemsCompletedAnalgesiaUnited States
-
Mansoura UniversityCompleted
-
Cessatech A/SCompleted
-
Kalyra Pharmaceuticals, Inc.United States Department of Defense; PRA Health SciencesTerminated
Clinical Trials on Action Observation plus motor imagery
-
Istituto Clinico HumanitasNot yet recruitingHand Injuries | Motor Imagery | Action Observation
-
University of ValenciaRecruitingMotor Imagery | Therapeutic Exercise | Action ObservationSpain
-
University of ValenciaRecruitingMotor Imagery | Therapeutic Exercise | Action ObservationSpain
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown
-
Universidad Autonoma de MadridUnknown
-
Istanbul Medeniyet UniversityIstinye University; Ufuk UniversityRecruiting
-
Universidad Autonoma de MadridCompleted
-
Universidad Autonoma de MadridUnknown
-
Universidad Autonoma de MadridCentro Universitario La SalleCompleted
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown