PainNCT04022174
Effects of Action Observation and Motor Imagery on Orofacial Sensorimotor Variables
A study testing Moderate dosage training of action Observation and Motor imagery, Intensive dosage training of action observation and motor imagery and Intensive dosage orofacial exercises in people with Pain, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main objective of the present study was to evaluate the effects of different dosages of action observation (AO) and motor imagery (MI) combined with an orofacial exercise program on pain pressure thresholds, lingual endurance and perceived exertion in asymptomatic subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Moderate dosage training of action Observation and Motor imagery, Intensive dosage training of action observation and motor imagery and Intensive dosage orofacial exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2019to 15 Aug 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
- healthy individuals with no pain
- aged between 18 and 65 years
- subjects with correct masticatory function and labial and lingual mobility
Who cannot join
- individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
- underage individuals
- individuals with orofacial pain or temporomandibular disorders at the time of the study
- subjects' complaint of toothache or tenderness to percussion.
Trial locations and contacts
1 site in 1 country.
Spain1 site
CSEU La Salle
Madrid, 28023
Roy La Touche, 917401980, roylatouche@yahoo.es
About this study
The main objective of the present study was to evaluate the effects of different dosages of action observation (AO) and motor imagery (MI) combined with an orofacial exercise program on pain pressure thresholds, lingual endurance and perceived exertion in asymptomatic subjects.
- Conditions
- Pain
- Being tested
- Moderate dosage training of action Observation and Motor imagery, Intensive dosage training of action observation and motor imagery, Intensive dosage orofacial exercises, Moderate dosage orofacial exercises
- Keywords
- Motor Imagery, Action observation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate dosage training of action Observation and Motor imageryBehavioural
Motor imagery and action observation of orofacial exercises with moderate dosage
Intensive dosage training of action observation and motor imageryBehavioural
Motor imagery and action observation of the orofacial exercises with intensive dosage
Intensive dosage orofacial exercisesBiological
Orofacial exercises with high intensity
Moderate dosage orofacial exercisesBehavioural
Orofacial exercises with moderate intensity
| Study group | Role | What they receive |
|---|---|---|
| Moderate dosage training | Experimental | Not described Receives: Behavioral: Moderate dosage training of action Observation and Motor imagery; Behavioral: Moderate dosage orofacial exercises |
| Intensive dosage training | Experimental | Not described Receives: Behavioral: Intensive dosage training of action observation and motor imagery; Biological: Intensive dosage orofacial exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure thresholds (PPTs)
PPT is defined as the minimal amount of pressure where a sense of pressure first changes to pain. The mechanical pressure algometer (Force Ten TM FDX Digital Force Gage) used in this study consisted of a round rubber disk (area, 1 cm2) attached to a pressure (force) gauge. The gauge displays values in kilograms but, because the surface of the rubber tip is 1 cm2, the readings are expressed in kg/cm2. The range of values of the pressure algometer is 0 to 10 kg, with 0.1-kg divisions. The pressure was applied at a rate of 0.31 kg/second (Chesterton et al. 2007).
Measured: Change from baseline and immediately post-intervention
Lingual muscle endurance
Lingual muscle endurance is assessed using the Iowa Oral Performance Instrument (IOPI) (Adams et al. 2015). The measurement of muscular endurance was carried out by placing a plastic bulb with oblong air content on the hard palate, posterior to the central incisor teeth. The participants were asked to elevate the lingual (through anterior and posterior lingual region) to press the instrument with the maximum possible force for 3 seconds, while monitoring the force exerted, quantified in Newtons Adams et al. (2015) found moderate to strong reliability for anterior (ICC: 0.58-0.77) and posterior (ICC 0.77-0.84) tongue strength.
Measured: Change from baseline and immediately post-intervention
Perceived exertion
The Borg scale of perceived effort measures the entire range of effort that the individual perceives when exercising. This scale gives criteria to make adjustments to the intensity of exercise, that is. To the workload, and thus predict and dictate the different intensities of exercise in sports and in medical rehabilitation (BORG, 1982). It can also be used in athletics, astronautics, industry and military environments, as well as in everyday situations. The concept of perceived effort is a subjective evaluation that indicates the subject's opinion regarding the intensity of the work carried out (MORGAN, 1973). The subject doing the exercise must designate a number, from 1 to 20, to represent the subjective sensation of the amount of work performed and higher values represent more perceived exertion
Measured: Change from baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start12 Jul 2019 (estimated)
- Primary completion12 Aug 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
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
- NCT04022174
- Sponsor's protocol ID
- uammadrid10
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 22 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 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation and Motor Imagery on Orofacial Sensorimotor Variables
- ClinicalTrials.gov ID
- NCT04022174
- Acronym / sponsor ID
- uammadrid10
- Conditions
- Pain
- Keywords
- Motor Imagery, Action observation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 12 Jul 2019 (estimated)
- Primary completion
- 12 Aug 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 16 Jul 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.
The main objective of the present study was to evaluate the effects of different dosages of action observation (AO) and motor imagery (MI) combined with an orofacial exercise program on pain pressure thresholds, lingual endurance and perceived exertion in asymptomatic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate dosage training | Experimental | Behavioral: Moderate dosage training of action Observation and Motor imagery, Behavioral: Moderate dosage orofacial exercises |
| Intensive dosage training | Experimental | Behavioral: Intensive dosage training of action observation and motor imagery, Biological: Intensive dosage orofacial exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy individuals with no pain
- aged between 18 and 65 years
- subjects with correct masticatory function and labial and lingual mobility
Key exclusion criteria (4 listed)
- individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
- underage individuals
- individuals with orofacial pain or temporomandibular disorders at the time of the study
- subjects' complaint of toothache or tenderness to percussion.
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 |
|---|---|---|
| Moderate dosage training of action Observation and Motor imageryMotor imagery and action observation of orofacial exercises with moderate dosage | Behavioural | Moderate dosage training |
| Intensive dosage training of action observation and motor imageryMotor imagery and action observation of the orofacial exercises with intensive dosage | Behavioural | Intensive dosage training |
| Intensive dosage orofacial exercisesOrofacial exercises with high intensity | Biological | Intensive dosage training |
| Moderate dosage orofacial exercisesOrofacial exercises with moderate intensity | Behavioural | Moderate dosage training |
Primary outcome
Pain pressure thresholds (PPTs)
Time frame: Change from baseline and immediately post-intervention
PPT is defined as the minimal amount of pressure where a sense of pressure first changes to pain. The mechanical pressure algometer (Force Ten TM FDX Digital Force Gage) used in this study consisted of a round rubber disk (area, 1 cm2) attached to a pressure (force) gauge. The gauge displays values in kilograms but, because the surface of the rubber tip is 1 cm2, the readings are expressed in kg/cm2. The range of values of the pressure algometer is 0 to 10 kg, with 0.1-kg divisions. The pressure was applied at a rate of 0.31 kg/second (Chesterton et al. 2007).
Lingual muscle endurance
Time frame: Change from baseline and immediately post-intervention
Lingual muscle endurance is assessed using the Iowa Oral Performance Instrument (IOPI) (Adams et al. 2015). The measurement of muscular endurance was carried out by placing a plastic bulb with oblong air content on the hard palate, posterior to the central incisor teeth. The participants were asked to elevate the lingual (through anterior and posterior lingual region) to press the instrument with the maximum possible force for 3 seconds, while monitoring the force exerted, quantified in Newtons Adams et al. (2015) found moderate to strong reliability for anterior (ICC: 0.58-0.77) and posterior (ICC 0.77-0.84) tongue strength.
Perceived exertion
Time frame: Change from baseline and immediately post-intervention
The Borg scale of perceived effort measures the entire range of effort that the individual perceives when exercising. This scale gives criteria to make adjustments to the intensity of exercise, that is. To the workload, and thus predict and dictate the different intensities of exercise in sports and in medical rehabilitation (BORG, 1982). It can also be used in athletics, astronautics, industry and military environments, as well as in everyday situations. The concept of perceived effort is a subjective evaluation that indicates the subject's opinion regarding the intensity of the work carried out (MORGAN, 1973). The subject doing the exercise must designate a number, from 1 to 20, to represent the subjective sensation of the amount of work performed and higher values represent more perceived exertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
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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?
A study testing Moderate dosage training of action Observation and Motor imagery, Intensive dosage training of action observation and motor imagery and Intensive dosage orofacial exercises in people with Pain, 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 3 inclusion and 4 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 22 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy La Touche (+349174019803, roylatouche@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure thresholds (PPTs) (time frame: Change from baseline and immediately post-intervention). The study lists 3 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 22 Jul 2019.