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Clinical Trials/NCT04578626
NCT04578626
Completed
N/A

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

Poliambulatorio Physio Power1 site in 1 country17 target enrollmentJanuary 6, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Asymptomatic State
Sponsor
Poliambulatorio Physio Power
Enrollment
17
Locations
1
Primary Endpoint
mean of sternocleidomastoid muscle thickness
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
February 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Poliambulatorio Physio Power
Responsible Party
Principal Investigator
Principal Investigator

Alice Botticchio

Principal investigator

Poliambulatorio Physio Power

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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)

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)

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)

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)

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)

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)

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)

Secondary Outcomes

  • mean of maximum mouth opening(Baseline (before the treatment), one month after the treatment)

Study Sites (1)

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