Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling
12. Oktober 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
17
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Madrid
-
Pozuelo De Alarcón, Madrid, Spanien, 28223
- Universidad Francisco de Vitoria
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: dry needling group
Dry needling treatment on right or left side of the face (depending on randomization)
|
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.
|
|
Kein Eingriff: control group
No treatment on left or right side of the face (depending on randomization)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
mean of temporomandibular joint disc thickness
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
mean of maximum mouth opening
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Alice Botticchio, PT, OMPT, Poliambulatorio PhysioPower, Brescia, Italy
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Turo D, Otto P, Hossain M, Gebreab T, Armstrong K, Rosenberger WF, Shao H, Shah JP, Gerber LH, Sikdar S. Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain. J Ultrasound Med. 2015 Dec;34(12):2149-61. doi: 10.7863/ultra.14.08033. Epub 2015 Oct 21.
- Emshoff R, Bertram S, Rudisch A, Gassner R. The diagnostic value of ultrasonography to determine the temporomandibular joint disk position. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Dec;84(6):688-96. doi: 10.1016/s1079-2104(97)90374-7.
- Raadsheer MC, Van Eijden TM, Van Spronsen PH, Van Ginkel FC, Kiliaridis S, Prahl-Andersen B. A comparison of human masseter muscle thickness measured by ultrasonography and magnetic resonance imaging. Arch Oral Biol. 1994 Dec;39(12):1079-84. doi: 10.1016/0003-9969(94)90061-2.
- Cagnie B, Dewitte V, Barbe T, Timmermans F, Delrue N, Meeus M. Physiologic effects of dry needling. Curr Pain Headache Rep. 2013 Aug;17(8):348. doi: 10.1007/s11916-013-0348-5.
- Smith P, Mosscrop D, Davies S, Sloan P, Al-Ani Z. The efficacy of acupuncture in the treatment of temporomandibular joint myofascial pain: a randomised controlled trial. J Dent. 2007 Mar;35(3):259-67. doi: 10.1016/j.jdent.2006.09.004. Epub 2006 Nov 13.
- Hides J, Richardson C, Jull G, Davies S. Ultrasound imaging in rehabilitation. Aust J Physiother. 1995;41(3):187-93. doi: 10.1016/S0004-9514(14)60429-3.
- Hodges PW. Ultrasound imaging in rehabilitation: just a fad? J Orthop Sports Phys Ther. 2005 Jun;35(6):333-7. doi: 10.2519/jospt.2005.0106. No abstract available.
- Teyhen DS. Rehabilitative ultrasound imaging for assessment and treatment of musculoskeletal conditions. Man Ther. 2011 Feb;16(1):44-5. doi: 10.1016/j.math.2010.06.012. Epub 2010 Aug 1. No abstract available.
- Bubnov RV. The use of trigger point "dry" needling under ultrasound guidance for the treatment of myofascial pain (technological innovation and literature review). Lik Sprava. 2010 Jul-Sep;(5-6):56-64.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
6. Januar 2020
Primärer Abschluss (Tatsächlich)
20. Februar 2020
Studienabschluss (Tatsächlich)
20. Februar 2020
Studienanmeldedaten
Zuerst eingereicht
1. Oktober 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Oktober 2020
Zuerst gepostet (Tatsächlich)
8. Oktober 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Oktober 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Oktober 2020
Zuletzt verifiziert
1. Oktober 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- US-DN-01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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