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Completed

NCT Number: NCT04578626

Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

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.

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Key information

Conditions

Asymptomatic State Asymptomatic Diseases Disease Attributes Masticatory Muscles Pathologic Processes Pathological Conditions, Signs and Symptoms Temporomandibular Joint

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Device

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.

Primary outcomes

  1. mean of temporomandibular joint disc thickness

    Time frame: Baseline (before the treatment), immediately after the treatment, one month after the treatment

    the distance between the opposing surfaces of the disc (cm)

  2. mean of temporal muscle thickness

    Time frame: 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)

  3. mean of masseter muscle thickness

    Time frame: 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)

  4. mean of masseter muscle width

    Time frame: 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)

  5. mean of masseter muscle cross-sectional area

    Time frame: 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)

  6. mean of sternocleidomastoid muscle thickness

    Time frame: 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)

  7. mean of sternocleidomastoid muscle width

    Time frame: 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)

  8. mean of sternocleidomastoid muscle cross-sectional area

    Time frame: 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)

Secondary outcomes

  1. mean of maximum mouth opening

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Poliambulatorio Physio Power

Other

Collaborators

  • Universidad Francisco de Vitoria

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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