Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

October 12, 2020 updated by: Alice Botticchio, Poliambulatorio Physio Power

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Universidad Francisco de Vitoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
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)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
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)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
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)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
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)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
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)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
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)
Baseline (before the treatment), immediately after the treatment, one month after the treatment
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)
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
Time Frame: 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)
Baseline (before the treatment), one month after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poliambulatorio Physio Power

Collaborators

Universidad Francisco de Vitoria

Investigators

  • Principal Investigator: Alice Botticchio, PT, OMPT, Poliambulatorio PhysioPower, Brescia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-DN-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We are not intentioned to share the participant data as our outcomes are subjectively evaluated by the use of ultrasonography. We don't believe it will be helpful for other researches as the results will be interpreted by our assessors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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