AnalgesiaNCT03959449
Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects
A study testing Action Observation plus motor imagery, Motor imagery and Exercise plus action Observation and motor imagery in people with Analgesia and Exercise, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Action Observation plus motor imagery, Motor imagery and Exercise plus action Observation and motor imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2019to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 60
- Healthy and with no pain subjects
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Action Observation plus motor imagery, Motor imagery, Exercise plus action Observation and motor imagery
- Keywords
- Motor imagery, Action observation, Hypoalgesia
- Medical subject headings
- Agnosia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation plus motor imageryBehavioural
Action observation (video) and motor imagery of running.
Motor imageryBehavioural
Motor imagery of running
Exercise plus action Observation and motor imageryBehavioural
Real exercise of running during 6 min plus action observation (video) and motor imagery of running.
| Study group | Role | What they receive |
|---|---|---|
| Action Observation and Motor imagery | Experimental | Not described Receives: Behavioral: Action Observation plus motor imagery |
| Motor Imagery | Active comparator | Not described Receives: Behavioral: Motor imagery |
| Exercise plus motor imagery and action observation | Experimental | Not described Receives: Behavioral: Exercise plus action Observation and motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline and immediately post-intervention
Secondary outcomes (6)
Visual and Kinesthetic Motor Imagery Ability
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).
Measured: Immediately before the intervention
The degree of physical activity
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.
Measured: Immediately before the intervention
Kinesiophobia
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
Measured: Immediately before the intervention
Electrodermal Activity
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
Measured: Change in electrodermal activity after 5 minutes post-intervention
Respiration Rate
Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap
Measured: Change in electrodermal activity after 5 minutes post-intervention
Respiration Rate
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.
Measured: Change in electrodermal activity after 5 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start5 Jun 2019
- Primary completion30 Jun 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959449
- Sponsor's protocol ID
- uammadrid8
- Status last verified
- Jul 2019
- First submitted
- 20 May 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects
- ClinicalTrials.gov ID
- NCT03959449
- Acronym / sponsor ID
- uammadrid8
- Keywords
- Motor imagery, Action observation, Hypoalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Action Observation and Motor imagery | Experimental | Behavioral: Action Observation plus motor imagery |
| Motor Imagery | Active comparator | Behavioral: Motor imagery |
| Exercise plus motor imagery and action observation | Experimental | Behavioral: Exercise plus action Observation and motor imagery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 60
- Healthy and with no pain subjects
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation plus motor imageryAction observation (video) and motor imagery of running. | Behavioural | Action Observation and Motor imagery |
| Motor imageryMotor imagery of running | Behavioural | Motor Imagery |
| Exercise plus action Observation and motor imageryReal exercise of running during 6 min plus action observation (video) and motor imagery of running. | Behavioural | Exercise plus motor imagery and action observation |
Primary outcome
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
6 secondary outcomes
Visual and Kinesthetic Motor Imagery Ability
Time frame: Immediately before the intervention
The degree of physical activity
Time frame: Immediately before the intervention
Kinesiophobia
Time frame: Immediately before the intervention
Electrodermal Activity
Time frame: Change in electrodermal activity after 5 minutes post-intervention
Respiration Rate
Time frame: Change in electrodermal activity after 5 minutes post-intervention
Respiration Rate
Time frame: Change in electrodermal activity after 5 minutes post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation plus motor imagery, Motor imagery and Exercise plus action Observation and motor imagery in people with Analgesia and Exercise, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: Change from baseline and immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.