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Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

12. oktober 2020 opdateret af: Alice Botticchio, Poliambulatorio Physio Power

Morphological Changes in Asymptomatic Perimandibular Muscles After Dry Needling Assessed With Rehabilitative Ultrasound Imaging

The articular disc of temporomandibular joint and three muscles of the cervico-facial region (temporal, masseter, sternocleidomastoid) are evaluated by means of sonographic images to observe and measure their dimensions' changes after a dry needling intervention. The participants are asymptomatic subjects and will be randomly divided in 2 groups: half of them are treated on the right side of the face, while the other half on the left side. Our hypothesis is that ultrasonography can reveal changes in the structures measured on the treated side.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The trial is designed as a before-and-after study conducted on asymptomatic subjects. The aim is to assess temporomandibular joint and three perimandibular muscles (temporal, masseter, sternocleidomastoid) by means of rehabilitative ultrasound imaging, carried out by a novice clinician. These evaluations are performed before and after a dry needling treatment directed to the tree studied muscles of one side of the face. The side to be treated is randomly assigned by using a computer-generated randomization process, the other side is used as control.

One month after the treatment sonographic images are taken by the novice clinician and by an expert one. The aim is to assess the reliability of ultrasonography comparing the results of their assessments.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spanien, 28223
        • Universidad Francisco de Vitoria

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age major then 18 years
  • Must be asymptomatic in the face/head region at the time of the visit and in the previous 6 months.

Exclusion Criteria:

  • Pregnancy
  • medical history of systemic disease
  • current pharmacological therapy
  • history of recurrent headache and/or neck pain
  • presence of orofacial pain or temporomandibular symptoms assessed with the DC/TMD (Diagnostic Criteria for TemporoMandibular Disorders)
  • current use of a bite during sleep

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: dry needling group
Dry needling treatment on right or left side of the face (depending on randomization)
Enhed: dry needling
The use of filiform needles to stimulate muscles and connective tissues. The needle is inserted in a direction perpendicular to the skin, a local twitch response is looked for and, once found, the needle is kept in the muscle without moving for 10 seconds. No substances are injected.
Ingen indgriben: control group
No treatment on left or right side of the face (depending on randomization)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mean of temporomandibular joint disc thickness
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing surfaces of the disc (cm)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
mean of temporal muscle thickness
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing borders of the muscle, along the transverse axis of the muscle (cm)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
mean of masseter muscle thickness
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the superficial and the deep border of the muscle (cm)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
mean of masseter muscle width
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
mean of masseter muscle cross-sectional area
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the area of the muscle in transversal plan measured after drawing the outline of the muscle in an image obtained with the panoramic view function (cm2)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
mean of sternocleidomastoid muscle thickness
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the superficial and the deep border of the muscle (cm)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
mean of sternocleidomastoid muscle width
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
mean of sternocleidomastoid muscle cross-sectional area
Tidsramme: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the area of the muscle in transversal plan measured after drawing the outline of the muscle in an image obtained with the panoramic view function (cm2)
Baseline (before the treatment), immediately after the treatment, one month after the treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mean of maximum mouth opening
Tidsramme: Baseline (before the treatment), one month after the treatment
the distance between the superior border of inferior front teeth and the inferior border of superior front teeth (cm)
Baseline (before the treatment), one month after the treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Poliambulatorio Physio Power

Samarbejdspartnere

Universidad Francisco de Vitoria

Efterforskere

  • Ledende efterforsker: Alice Botticchio, PT, OMPT, Poliambulatorio PhysioPower, Brescia, Italy

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. januar 2020

Primær færdiggørelse (Faktiske)

20. februar 2020

Studieafslutning (Faktiske)

20. februar 2020

Datoer for studieregistrering

Først indsendt

1. oktober 2020

Først indsendt, der opfyldte QC-kriterier

6. oktober 2020

Først opslået (Faktiske)

8. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • US-DN-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

We are not intentioned to share the participant data as our outcomes are subjectively evaluated by the use of ultrasonography. We don't believe it will be helpful for other researches as the results will be interpreted by our assessors.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Asymptomatisk tilstand

Kliniske forsøg med dry needling

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