Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

Sponsor
Poliambulatorio Physio Power (Other)
Overall Status
Completed
CT.gov ID
NCT04578626
Collaborator
Universidad Francisco de Vitoria (Other)
17
1
2
1.5
11.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: dry needling
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Morphological Changes in Asymptomatic Perimandibular Muscles After Dry Needling Assessed With Rehabilitative Ultrasound Imaging
Actual Study Start Date :
Jan 6, 2020
Actual Primary Completion Date :
Feb 20, 2020
Actual Study Completion Date :
Feb 20, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Secondary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Francisco de Vitoria Pozuelo De Alarcón Madrid Spain 28223

Sponsors and Collaborators

  • Poliambulatorio Physio Power
  • Universidad Francisco de Vitoria

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Alice Botticchio, Principal investigator, Poliambulatorio Physio Power
ClinicalTrials.gov Identifier:
NCT04578626
Other Study ID Numbers:
  • US-DN-01
First Posted:
Oct 8, 2020
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alice Botticchio, Principal investigator, Poliambulatorio Physio Power
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2020