AnalgesiaNCT04548323
Hypoalgesic Effects of Walking and Running Imagined
An observational study of Analgesia, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Motor imagery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2020to 30 Jul 2021
- Phase
- Observational
- 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
Study population: Healthy subjects divided by their physical activity levels.
Who may be able to join
- asymptomatic participants
- men and women aged 18 to 65 years
Who cannot join
- insomnia
- nausea
- headache
- pregnancy
- use of painkillers in the last 24 hours
- presence of metal inside the head
Show all 10Show fewer
- pacemaker
- wound on the area of electrodes' application
- drug consumption; (j) recent application of tDCS
- psychiatric disease impeding understanding of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoalgesic Effects of Walking and Running Imagined in Sedentary Subjects and With High Levels of Physical Activity: A Prospective Cohort Study
The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity.
- Conditions
- Analgesia
- Being tested
- Motor imagery
- Keywords
- Motor imagery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imageryBehavioural
Subjects will perform motor imagery tasks on the motor gestures of running and walking.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery in Sedentary subjects | Not described Receives: Behavioral: Motor imagery | |
| Motor Imagery active subjects | Not described Receives: Behavioral: 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
Temporal sumation
Temporal summation is a somatosensory measure that is performed by making small punctures in the area of interest.
Measured: Change from baseline and immediately post-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 from baseline and immediately 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 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 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 from baseline and immediately post-intervention.
Salivary stress
The Salivary Stress Test is a study that assesses fatigue and the type of stress (acute, moderate or chronic) presented by the subject.
Measured: Change from baseline and immediately post-intervention.
Secondary outcomes (2)
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.
Measured: Change from baseline and immediately post-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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548323
- Sponsor's protocol ID
- uammadrid32
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoalgesic Effects of Walking and Running Imagined in Sedentary Subjects and With High Levels of Physical Activity: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04548323
- Acronym / sponsor ID
- uammadrid32
- Conditions
- Analgesia
- Keywords
- Motor imagery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 14 Sep 2020 (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.
The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery in Sedentary subjects | – | Behavioral: Motor imagery |
| Motor Imagery active subjects | – | Behavioral: Motor imagery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects divided by their physical activity levels.
Key inclusion criteria (2 listed)
- asymptomatic participants
- men and women aged 18 to 65 years
Key exclusion criteria (10 listed)
- insomnia
- nausea
- headache
- pregnancy
- use of painkillers in the last 24 hours
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 |
|---|---|---|
| Motor imagerySubjects will perform motor imagery tasks on the motor gestures of running and walking. | Behavioural | Motor Imagery active subjects, Motor Imagery in Sedentary subjects |
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
Temporal sumation
Time frame: Change from baseline and immediately post-intervention
Temporal summation is a somatosensory measure that is performed by making small punctures in the area of interest.
Electrodermal activity
Time frame: Change from baseline and immediately 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 from baseline and immediately 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.
Heart rate
Time frame: Change from baseline and immediately 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.
Salivary stress
Time frame: Change from baseline and immediately post-intervention.
The Salivary Stress Test is a study that assesses fatigue and the type of stress (acute, moderate or chronic) presented by the subject.
2 secondary outcomes
Visual and Kinesthetic Motor Imagery Ability
Time frame: Change from baseline and immediately post-intervention
The degree of physical activity
Time frame: Immediately before the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia, 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 10 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: status not confirmed, as of the sponsor's last update on 14 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy A La Tocuhe, physiotherapist PhD (917401980 ext. 313, roylatouche@lasallecampus.es), or a site near the patient. 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). The study lists 6 primary outcomes in all. 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 14 Sep 2020.