Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

NCT ID: NCT04578626

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-02-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asymptomatic State Temporomandibular Joint Masticatory Muscles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dry needling group

Dry needling treatment on right or left side of the face (depending on randomization)

Group Type EXPERIMENTAL

dry needling

Intervention Type 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.

control group

No treatment on left or right side of the face (depending on randomization)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Francisco de Vitoria

OTHER

Sponsor Role collaborator

Poliambulatorio Physio Power

OTHER

Sponsor Role lead

Responsible Party

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Alice Botticchio

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alice Botticchio, PT, OMPT

Role: PRINCIPAL_INVESTIGATOR

Poliambulatorio PhysioPower, Brescia, Italy

Locations

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Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, Spain

Site Status

Countries

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Spain

References

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Other Identifiers

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US-DN-01

Identifier Type: -

Identifier Source: org_study_id

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