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Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04578626
Enrollment
17
Registered
2020-10-08
Start date
2020-01-06
Completion date
2020-02-20
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic State, Masticatory Muscles, Temporomandibular Joint

Keywords

ultrasonography, dry needling, physical therapy

Brief summary

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

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.

Interventions

DEVICEdry 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.

Sponsors

Universidad Francisco de Vitoria
CollaboratorOTHER
Poliambulatorio Physio Power
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
mean of temporomandibular joint disc thicknessBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe distance between the opposing surfaces of the disc (cm)
mean of temporal muscle thicknessBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe distance between the opposing borders of the muscle, along the transverse axis of the muscle (cm)
mean of masseter muscle thicknessBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe distance between the superficial and the deep border of the muscle (cm)
mean of masseter muscle widthBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
mean of masseter muscle cross-sectional areaBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe 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)
mean of sternocleidomastoid muscle thicknessBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe distance between the superficial and the deep border of the muscle (cm)
mean of sternocleidomastoid muscle widthBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
mean of sternocleidomastoid muscle cross-sectional areaBaseline (before the treatment), immediately after the treatment, one month after the treatmentthe 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

MeasureTime frameDescription
mean of maximum mouth openingBaseline (before the treatment), one month after the treatmentthe distance between the superior border of inferior front teeth and the inferior border of superior front teeth (cm)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026