Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects

• ClinicalTrials.gov Identifier: NCT03959449
• Recruitment Status: Completed
• First Posted: May 22, 2019
• Last Update Posted: July 23, 2019
• Sponsor: Universidad Autonoma de Madrid
• Information provided by (Responsible Party): Roy La Touche Arbizu, Universidad Autonoma de Madrid

Tracking Information

• First Submitted Date: May 20, 2019
• First Posted Date: May 22, 2019
• Last Update Posted Date: July 23, 2019
• Actual Study Start Date: June 5, 2019
• Actual Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 20, 2019)

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03959449 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 22, 2019)

• 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).
• 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.
• 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
• 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
• 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
• 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.

Original Secondary Outcome Measures (submitted: May 20, 2019)

• 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).
• 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 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
• 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
• 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
• 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
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects
• Official Title: Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects
• Brief Summary: 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Analgesia
• Exercise

Intervention

• Behavioral: Action Observation plus motor imagery
  Action observation (video) and motor imagery of running.
• Behavioral: Motor imagery
  Motor imagery of running
• Behavioral: Exercise plus action Observation and motor imagery
  Real exercise of running during 6 min plus action observation (video) and motor imagery of running.

Study Arms

• Experimental: Action Observation and Motor imagery
  Intervention: Behavioral: Action Observation plus motor imagery
• Active Comparator: Motor Imagery
  Intervention: Behavioral: Motor imagery
• Experimental: Exercise plus motor imagery and action observation
  Intervention: Behavioral: Exercise plus action Observation and motor imagery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 20, 2019): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 15, 2019
• Actual Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03959449
• Other Study ID Numbers: uammadrid8
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Roy La Touche Arbizu, Universidad Autonoma de Madrid
• Study Sponsor: Universidad Autonoma de Madrid
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universidad Autonoma de Madrid
• Verification Date: July 2019