Asymptomatic StateNCT04578626

Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

A study testing dry needling in people with Asymptomatic State and Temporomandibular Joint, run by Poliambulatorio Physio Power at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Asymptomatic State, Temporomandibular Joint, Masticatory Muscles
What is being tested?: dry needling
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteSpain
Study dates: 6 Jan 2020to 20 Feb 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad Francisco de Vitoria
Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions: Asymptomatic State, Temporomandibular Joint, Masticatory Muscles
Being tested: dry needling
Keywords: ultrasonography, dry needling, physical therapy
Medical subject headings: Asymptomatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dry needlingDevice
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.

Study groups in NCT04578626
Study group	Role	What they receive
dry needling group	Experimental	Dry needling treatment on right or left side of the face (depending on randomization) Receives: Device: dry needling
control group	No intervention	No treatment on left or right side of the face (depending on randomization)

What is being measured

The primary outcome is the main question the study is designed to answer.

mean of temporomandibular joint disc thickness
the distance between the opposing surfaces of the disc (cm)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline (before the treatment), immediately after the treatment, one month after the treatment

Secondary outcomes (1)

mean of maximum mouth opening
the distance between the superior border of inferior front teeth and the inferior border of superior front teeth (cm)
Measured: Baseline (before the treatment), one month after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202020 Feb 2020

First posted8 Oct 2020
Study start6 Jan 2020
Primary completion20 Feb 2020
Study completion20 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Asymptomatic StateStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04578626
Sponsor's protocol ID: US-DN-01
Status last verified: Oct 2020
First submitted: 1 Oct 2020
Last updated: 14 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784
de-Pedro-Herraez M, Mesa-Jimenez J, Fernandez-de-Las-Penas C, de-la-Hoz-Aizpurua JL. Myogenic temporomandibular disorders: Clinical systemic comorbidities in a female population sample. Med Oral Patol Oral Cir Bucal. 2016 Nov 1;21(6):e784-792. doi: 10.4317/medoral.21249.
PubMed 27694784
Ries LG, Alves MC, Berzin F. Asymmetric activation of temporalis, masseter, and sternocleidomastoid muscles in temporomandibular disorder patients. Cranio. 2008 Jan;26(1):59-64. doi: 10.1179/crn.2008.008.
PubMed 18290526
Dahlstrom L, Carlsson GE. Temporomandibular disorders and oral health-related quality of life. A systematic review. Acta Odontol Scand. 2010 Mar;68(2):80-5. doi: 10.3109/00016350903431118.
PubMed 20141363
Oliveira LK, Almeida Gde A, Lelis ER, Tavares M, Fernandes Neto AJ. Temporomandibular disorder and anxiety, quality of sleep, and quality of life in nursing professionals. Braz Oral Res. 2015;29:S1806-83242015000100265. doi: 10.1590/1807-3107BOR-2015.vol29.0070.
PubMed 26039910
Weiss RC, Oostrom-Ram T. Inhibitory effects of ribavirin alone or combined with human alpha interferon on feline infectious peritonitis virus replication in vitro. Vet Microbiol. 1989 Jul;20(3):255-65. doi: 10.1016/0378-1135(89)90049-7.
PubMed 2549687
Emshoff R, Bertram S, Strobl H. Ultrasonographic cross-sectional characteristics of muscles of the head and neck. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Jan;87(1):93-106. doi: 10.1016/s1079-2104(99)70302-1.
PubMed 9927088
Djordjevic O, Djordjevic A, Konstantinovic L. Interrater and intrarater reliability of transverse abdominal and lumbar multifidus muscle thickness in subjects with and without low back pain. J Orthop Sports Phys Ther. 2014 Dec;44(12):979-88. doi: 10.2519/jospt.2014.5141. Epub 2014 Nov 3.
PubMed 25366083
Strini PJ, Strini PJ, Barbosa Tde S, Gaviao MB. Assessment of thickness and function of masticatory and cervical muscles in adults with and without temporomandibular disorders. Arch Oral Biol. 2013 Sep;58(9):1100-8. doi: 10.1016/j.archoralbio.2013.04.006. Epub 2013 May 16.
PubMed 23684155
Pallegama RW, Ranasinghe AW, Weerasinghe VS, Sitheeque MA. Influence of masticatory muscle pain on electromyographic activities of cervical muscles in patients with myogenous temporomandibular disorders. J Oral Rehabil. 2004 May;31(5):423-9. doi: 10.1111/j.1365-2842.2004.01266.x.
PubMed 15140167
Fedorowicz Z, van Zuuren EJ, Schoones J. Botulinum toxin for masseter hypertrophy. Cochrane Database Syst Rev. 2013 Sep 9;2013(9):CD007510. doi: 10.1002/14651858.CD007510.pub3.
PubMed 24018587
Ariji Y, Sakuma S, Izumi M, Sasaki J, Kurita K, Ogi N, Nojiri M, Nakagawa M, Takenaka M, Katsuse S, Ariji E. Ultrasonographic features of the masseter muscle in female patients with temporomandibular disorder associated with myofascial pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Sep;98(3):337-41. doi: 10.1016/j.tripleo.2004.06.068.
PubMed 15356473
Gonzalez-Perez LM, Infante-Cossio P, Granados-Nunez M, Urresti-Lopez FJ, Lopez-Martos R, Ruiz-Canela-Mendez P. Deep dry needling of trigger points located in the lateral pterygoid muscle: Efficacy and safety of treatment for management of myofascial pain and temporomandibular dysfunction. Med Oral Patol Oral Cir Bucal. 2015 May 1;20(3):e326-33. doi: 10.4317/medoral.20384.
PubMed 25662558
Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.
PubMed 25143704
Diracoglu D, Vural M, Karan A, Aksoy C. Effectiveness of dry needling for the treatment of temporomandibular myofascial pain: a double-blind, randomized, placebo controlled study. J Back Musculoskelet Rehabil. 2012;25(4):285-90. doi: 10.3233/BMR-2012-0338.
PubMed 23220812

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Asymptomatic State trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Morphological Changes in Asymptomatic Perimandibular Muscles After Dry Needling Assessed With Rehabilitative Ultrasound Imaging
ClinicalTrials.gov ID: NCT04578626
Acronym / sponsor ID: US-DN-01
Conditions: Asymptomatic State, Temporomandibular Joint, Masticatory Muscles
Keywords: ultrasonography, dry needling, physical therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Poliambulatorio Physio PowerUniversity, hospital or other
Collaborators: Universidad Francisco de Vitoria
Study start: 6 Jan 2020 (actual)
Primary completion: 20 Feb 2020 (actual)
Study completion: 20 Feb 2020 (actual)
First posted: 8 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
dry needling group	Experimental	Device: dry needlingDry needling treatment on right or left side of the face (depending on randomization)
control group	No intervention	–No treatment on left or right side of the face (depending on randomization)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dry needlingThe 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.	Device	dry needling group

Primary outcome

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 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 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 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 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 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)
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)

1 secondary outcome

mean of maximum mouth opening
Time frame: Baseline (before the treatment), one month after the treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
Background: PubMed 27694784de-Pedro-Herraez M, Mesa-Jimenez J, Fernandez-de-Las-Penas C, de-la-Hoz-Aizpurua JL. Myogenic temporomandibular disorders: Clinical systemic comorbidities in a female population sample. Med Oral Patol Oral Cir Bucal. 2016 Nov 1;21(6):e784-792. doi: 10.4317/medoral.21249.
Background: PubMed 18290526Ries LG, Alves MC, Berzin F. Asymmetric activation of temporalis, masseter, and sternocleidomastoid muscles in temporomandibular disorder patients. Cranio. 2008 Jan;26(1):59-64. doi: 10.1179/crn.2008.008.
Background: PubMed 20141363Dahlstrom L, Carlsson GE. Temporomandibular disorders and oral health-related quality of life. A systematic review. Acta Odontol Scand. 2010 Mar;68(2):80-5. doi: 10.3109/00016350903431118.
Background: PubMed 26039910Oliveira LK, Almeida Gde A, Lelis ER, Tavares M, Fernandes Neto AJ. Temporomandibular disorder and anxiety, quality of sleep, and quality of life in nursing professionals. Braz Oral Res. 2015;29:S1806-83242015000100265. doi: 10.1590/1807-3107BOR-2015.vol29.0070.
Background: PubMed 2549687Weiss RC, Oostrom-Ram T. Inhibitory effects of ribavirin alone or combined with human alpha interferon on feline infectious peritonitis virus replication in vitro. Vet Microbiol. 1989 Jul;20(3):255-65. doi: 10.1016/0378-1135(89)90049-7.
Background: PubMed 9927088Emshoff R, Bertram S, Strobl H. Ultrasonographic cross-sectional characteristics of muscles of the head and neck. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Jan;87(1):93-106. doi: 10.1016/s1079-2104(99)70302-1.
Background: PubMed 25366083Djordjevic O, Djordjevic A, Konstantinovic L. Interrater and intrarater reliability of transverse abdominal and lumbar multifidus muscle thickness in subjects with and without low back pain. J Orthop Sports Phys Ther. 2014 Dec;44(12):979-88. doi: 10.2519/jospt.2014.5141. Epub 2014 Nov 3.
Background: PubMed 23684155Strini PJ, Strini PJ, Barbosa Tde S, Gaviao MB. Assessment of thickness and function of masticatory and cervical muscles in adults with and without temporomandibular disorders. Arch Oral Biol. 2013 Sep;58(9):1100-8. doi: 10.1016/j.archoralbio.2013.04.006. Epub 2013 May 16.
Background: PubMed 15140167Pallegama RW, Ranasinghe AW, Weerasinghe VS, Sitheeque MA. Influence of masticatory muscle pain on electromyographic activities of cervical muscles in patients with myogenous temporomandibular disorders. J Oral Rehabil. 2004 May;31(5):423-9. doi: 10.1111/j.1365-2842.2004.01266.x.
Background: PubMed 24018587Fedorowicz Z, van Zuuren EJ, Schoones J. Botulinum toxin for masseter hypertrophy. Cochrane Database Syst Rev. 2013 Sep 9;2013(9):CD007510. doi: 10.1002/14651858.CD007510.pub3.
Background: PubMed 15356473Ariji Y, Sakuma S, Izumi M, Sasaki J, Kurita K, Ogi N, Nojiri M, Nakagawa M, Takenaka M, Katsuse S, Ariji E. Ultrasonographic features of the masseter muscle in female patients with temporomandibular disorder associated with myofascial pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Sep;98(3):337-41. doi: 10.1016/j.tripleo.2004.06.068.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alice Botticchio, PT, OMPT principal investigator

Poliambulatorio PhysioPower, Brescia, Italy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing dry needling in people with Asymptomatic State and Temporomandibular Joint, run by Poliambulatorio Physio Power at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean of temporomandibular joint disc thickness (time frame: Baseline (before the treatment), immediately after the treatment, one month after the treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04578626, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.