Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

Temporomandibular Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578626
• Other study ID #: US-DN-01
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: February 20, 2020

Study information

• Verified date: October 2020
• Source: Poliambulatorio Physio Power
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Diseases
• Asymptomatic State
• Masticatory Muscles
• Temporomandibular Joint

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Francisco de Vitoria	Pozuelo De Alarcón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Poliambulatorio Physio Power	Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Dahlström 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. Review. — View Citation

de-Pedro-Herráez M, Mesa-Jiménez J, Fernández-de-Las-Peñas 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. — View Citation

Diraçoglu 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Fedorowicz Z, van Zuuren EJ, Schoones J. Botulinum toxin for masseter hypertrophy. Cochrane Database Syst Rev. 2013 Sep 9;(9):CD007510. doi: 10.1002/14651858.CD007510.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

Hodges PW. Ultrasound imaging in rehabilitation: just a fad? J Orthop Sports Phys Ther. 2005 Jun;35(6):333-7. — View Citation

Oliveira LK, Almeida Gde A, Lelis ÉR, Tavares M, Fernandes Neto AJ. Temporomandibular disorder and anxiety, quality of sleep, and quality of life in nursing professionals. Braz Oral Res. 2015;29. pii: S1806-83242015000100265. doi: 10.1590/1807-3107BOR-2015.vol29.0070. — View Citation

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. — View Citation

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. — View Citation

Ries LG, Alves MC, Bérzin F. Asymmetric activation of temporalis, masseter, and sternocleidomastoid muscles in temporomandibular disorder patients. Cranio. 2008 Jan;26(1):59-64. — View Citation

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 Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. — View Citation

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. Epub 2006 Nov 13. — View Citation

Strini PJ, Strini PJ, Barbosa Tde S, Gavião 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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	mean of maximum mouth opening	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

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