NCT04022174

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 8, 2019

Last Update Submit

July 19, 2019

Conditions

Keywords

Motor ImageryAction observation

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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

    Change from baseline and immediately post-intervention

Study Arms (2)

Moderate dosage training

EXPERIMENTAL
Behavioral: Moderate dosage training of action Observation and Motor imageryBehavioral: Moderate dosage orofacial exercises

Intensive dosage training

EXPERIMENTAL
Behavioral: Intensive dosage training of action observation and motor imageryBiological: Intensive dosage orofacial exercises

Interventions

Motor imagery and action observation of orofacial exercises with moderate dosage

Moderate dosage training

Motor imagery and action observation of the orofacial exercises with intensive dosage

Intensive dosage training

Orofacial exercises with high intensity

Intensive dosage training

Orofacial exercises with moderate intensity

Moderate dosage training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy individuals with no pain
  • aged between 18 and 65 years
  • subjects with correct masticatory function and labial and lingual mobility

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Luis Suso Marti

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 16, 2019

Study Start

July 12, 2019

Primary Completion

August 12, 2019

Study Completion

August 15, 2019

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations