Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

Study Overview
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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.

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

Conditions
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Asymptomatic State, Temporomandibular Joint, Masticatory Muscles

Intervention / Treatment
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* Device: dry needling


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dry needling group<br>Dry needling treatment on right or left side of the face (depending on randomization) | Device: dry needling<br>* 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.<br>|
| No Intervention: control group<br>No treatment on left or right side of the face (depending on randomization) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean of temporomandibular joint disc thickness | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean of maximum mouth opening | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, dry needling, physical therapy