Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

NCT04578626 | Completed

• 1 other identifier: US-DN-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Asymptomatic State; Temporomandibular Joint; Masticatory Muscles

Keywords

ultrasonography; dry needling; physical therapy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• mean of maximum mouth opening

  Baseline (before the treatment), one month after the treatment

Study Arms (2)

dry needling group

EXPERIMENTAL

Dry needling treatment on right or left side of the face (depending on randomization)

Device: dry needling

control group

NO INTERVENTION

No treatment on left or right side of the face (depending on randomization)

Interventions

dry needling DEVICE

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.

dry needling group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poliambulatorio Physio Power: lead
• Universidad Francisco de Vitoria: collaborator

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Related Publications (24)

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MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Alice Botticchio, PT, OMPT

  Poliambulatorio PhysioPower, Brescia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: January 6, 2020
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)