Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

Not Applicable

Completed

• Conditions: Masticatory Muscles; Temporomandibular Joint; Asymptomatic State
• Interventions: Device: dry needling

• Registration Number: NCT04578626
• Lead Sponsor: Poliambulatorio Physio Power

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.

Study Timeline

• Study Start: 2020-01-06
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2020-10
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-08
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dry needling group	dry needling	Dry needling treatment on right or left side of the face (depending on randomization)

Primary Outcome Measures

Name	Time	Method
mean of temporomandibular joint disc thickness	Baseline (before the treatment), immediately after the treatment, one month after the treatment	the distance between the opposing surfaces of the disc (cm)
mean of sternocleidomastoid muscle thickness	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)
mean of temporal muscle thickness	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)
mean of sternocleidomastoid muscle cross-sectional area	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)
mean of masseter muscle width	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)
mean of masseter muscle cross-sectional area	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)
mean of masseter muscle thickness	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)
mean of sternocleidomastoid muscle width	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)

Secondary Outcome Measures

Name	Time	Method
mean of maximum mouth opening	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)

Trial Locations

Locations (1)

Universidad Francisco de Vitoria; 🇪🇸 Pozuelo De Alarcón, Madrid, Spain