Effect of Active Mandibular Techniques and Specific Cranio-cervical Therapeutic Exercise in Patients With Temporomandibular Disorders and Bruxism (AMaCe-TB)
NCT ID: NCT07303361
Last Updated: 2025-12-24
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-11-22
2025-10-31
Brief Summary
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The trial will be conducted as a randomized controlled study with two parallel groups. The experimental group will receive a mandibular MET intervention delivered once weekly for four weeks, using an active resistance and controlled movement protocol based on three cycles of isometric contraction and passive stretching. In addition, participants will perform daily cranio-cervical motor control exercises at home, with weekly supervision. These exercises aim to enhance neuromuscular regulation of deep cervical flexors and extensors and improve cervical dissociation, symmetry, and alignment. The control group will receive standard clinical care supplemented by a single session of a modified suboccipital inhibition technique acting as a placebo procedure. They will also perform non-specific cervical mobility exercises at home over a four-week period.
The primary outcome will be the change in Pressure Pain Threshold (PPT) measured with a pressure algometer at trigger points located in the trapezius, masseter, external pterygoid, and digastric muscles. Secondary outcomes will include maximum mouth opening, pain intensity using a visual analog or numeric rating scale, craniocervical postural control assessed through standardized motor control evaluations, and mandibular movement behavior analyzed through visual or device-assisted kinematic assessment. Measurements will be taken at baseline, immediately after the intervention period, and during a follow-up assessment.
Participants will be adults aged 18 to 65 years with a clinical diagnosis of TMD associated with pain for at least three months and bruxism. All participants must provide informed consent prior to inclusion. Individuals with congenital malformations or cervical spine pathology, acute infectious or inflammatory disease, vestibular dysfunction, technical contraindications, recent manual therapy treatment (within one month), or recent use of analgesic, muscle relaxant, or anti-inflammatory medication (within eight hours) will be excluded.
The study aims to determine whether the application of active mandibular techniques combined with specific cervical motor control training results in superior improvements in function and pain compared to standard clinical management. Furthermore, the analysis will consider sex-related differences in baseline characteristics and treatment outcomes. Results from this trial may provide clinically relevant evidence to guide physiotherapeutic approaches for patients with TMD and bruxism, potentially improving therapeutic decision-making and long-term patient outcomes. The findings will be disseminated through publication in high-impact international journals and presentation at scientific conferences.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Specific technique Group
Patients will undergo the mandibular muscle energy technique, as well as specific craniocervical motor control exercises.
Mandibular Muscle Energy Technique
The mandibular muscle energy technique lasts approximately 3-4 minutes. The physical therapist stands next to the patient to use the jaw motion rehabilitation system, which will allow the technique to be applied through a system of controlled opening and resistance to closure, with a real assessment of the balance of mouth opening. The patient will be asked to open their mouth and it will be gently increased, while the patient's forehead is fixed, up to the patient's joint opening range. From this position, the patient will be asked to perform an isometric contraction of the masticatory muscles for approximately 3-5 seconds. This procedure will be performed in three cycles, with three contractions per cycle and a rest period between contractions of approximately 3-5 seconds. Patients will perform specific craniocervical motor control exercises for 4 weeks and will be monitored during weekly visits, where manual treatment will be performed using the mandibular muscle energy technique.
Stardard clinical treated group
Patients will receive standard clinical treatment and, in addition, a single session of treatment using a modified suboccipital inhibition technique plus non-specific cervical mobility exercises at home (flexion, extension, and rotation) for 4 weeks.
Modified suboccipital inhibition technique
The modified suboccipital inhibition technique will be performed at the beginning as a placebo technique. This technique will last 5 minutes. For this technique, the patient will lie on the table. The aim of this technique is to provide a stimulus as similar as possible to the original suboccipital inhibition technique, but without the force of movement. The patient will keep their eyes closed for the duration of the technique.
Interventions
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Mandibular Muscle Energy Technique
The mandibular muscle energy technique lasts approximately 3-4 minutes. The physical therapist stands next to the patient to use the jaw motion rehabilitation system, which will allow the technique to be applied through a system of controlled opening and resistance to closure, with a real assessment of the balance of mouth opening. The patient will be asked to open their mouth and it will be gently increased, while the patient's forehead is fixed, up to the patient's joint opening range. From this position, the patient will be asked to perform an isometric contraction of the masticatory muscles for approximately 3-5 seconds. This procedure will be performed in three cycles, with three contractions per cycle and a rest period between contractions of approximately 3-5 seconds. Patients will perform specific craniocervical motor control exercises for 4 weeks and will be monitored during weekly visits, where manual treatment will be performed using the mandibular muscle energy technique.
Modified suboccipital inhibition technique
The modified suboccipital inhibition technique will be performed at the beginning as a placebo technique. This technique will last 5 minutes. For this technique, the patient will lie on the table. The aim of this technique is to provide a stimulus as similar as possible to the original suboccipital inhibition technique, but without the force of movement. The patient will keep their eyes closed for the duration of the technique.
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of temporomandibular disorder and/or bruxism.
* Presence of pain and/or functional limitation.
* Ability to provide informed consent.
* Willingness to participate in the exercise program.
Exclusion Criteria
* Neurological disorders affecting motor control.
* Severe psychiatric disorders.
* Active inflammatory or rheumatologic conditions of the temporomandibular joint.
* Ongoing physiotherapeutic treatment targeting the studied region.
* Anti-inflammatory treatment 8 hours or less before the study.
* Pregnancy
* Inability to comply with the intervention protocol.
18 Years
ALL
No
Sponsors
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Gerencia Regional de Salud de Castilla y Leon
OTHER
Instituto de Investigación Biomédica de Salamanca
OTHER
Responsible Party
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Principal Investigators
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Antonio Márquez Vera, PhD
Role: PRINCIPAL_INVESTIGATOR
Centro Asistencial Universitario de Salamanca (CAUSA)
Jose Antonio Blanco Rueda, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centro Asistencial Universitario de Salamanca (CAUSA)
Locations
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Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, Spain
Countries
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References
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Mansilla Ferragut P, Boscá Gandía JJ. Efecto de la manipulación de la charnela occipito-atlo-axoidea en la apertura de la boca. Osteopatía Científica. 2008;3(2):45-51.
Mansilla-Ferragut P, Fernandez-de-Las Penas C, Alburquerque-Sendin F, Cleland JA, Bosca-Gandia JJ. Immediate effects of atlanto-occipital joint manipulation on active mouth opening and pressure pain sensitivity in women with mechanical neck pain. J Manipulative Physiol Ther. 2009 Feb;32(2):101-6. doi: 10.1016/j.jmpt.2008.12.003.
Bretischwerdt C, Rivas-Cano L, Palomeque-del-Cerro L, Fernandez-de-las-Penas C, Alburquerque-Sendin F. Immediate effects of hamstring muscle stretching on pressure pain sensitivity and active mouth opening in healthy subjects. J Manipulative Physiol Ther. 2010 Jan;33(1):42-7. doi: 10.1016/j.jmpt.2009.11.009.
Whittingham W, Nilsson N. Active range of motion in the cervical spine increases after spinal manipulation (toggle recoil). J Manipulative Physiol Ther. 2001 Nov-Dec;24(9):552-5. doi: 10.1067/mmt.2001.118979.
Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL; COG. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther. 2010 Aug;15(4):315-33. doi: 10.1016/j.math.2010.04.002. Epub 2010 May 26.
17. Fernandes Juca K, Claudio Suazo Galdames I. Posición Condilar en Apertura Oral Máxima. Una Evaluación con Imágenes de Resonancia Magnética. Int. J. Morphol. 2009; 27(3):867-71.
Fey MF. [Diagnostic DNA probes]. Schweiz Med Wochenschr. 1990 May 19;120(20):731-7. German.
15. Jiménez-Silva A, Peña-Durán C, Lee-Munoz X, Vergara-Núnez C, Tobar-Reyes J y Frugone-Zambra R. Patología temporomandibular asociada a masticación unilateral en adultos jóvenes. Rev Clin Periodoncia Implantol Rehabil Oral. 2016;9(2):125-31.
Aparicio EQ, Quirante LB, Blanco CR, Sendin FA. Immediate effects of the suboccipital muscle inhibition technique in subjects with short hamstring syndrome. J Manipulative Physiol Ther. 2009 May;32(4):262-9. doi: 10.1016/j.jmpt.2009.03.006.
12. Rodríguez Blanco C, Torres-Lagares D, Munuera Martínez PV, Oliva Pascual-Vaca A. Influencias de la relación maxilomandibular en el tratamiento postural mediante inhibición muscular. Osteopatía Científica. 2009;4(3):115-119
11. Gerez J, Figallo MA, Martínez PV, Rabadán M, Ortega MÁ, Vidal JA, Hernández MS. Short Term Application of the Muscular Inhibition Method of Strain/Counterstrain in the Treatment of Latent Myofascial Trigger Points of the Masticatory Musculature: A Randomized Controlled Trial. Clin Adv in Health Res. 2019; 1.1: 2-10.
Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
Olivo SA, Fuentes J, Major PW, Warren S, Thie NM, Magee DJ. The association between neck disability and jaw disability. J Oral Rehabil. 2010 Sep;37(9):670-9. doi: 10.1111/j.1365-2842.2010.02098.x. Epub 2010 May 27.
Gencosmanoglu H, Unluer NO, Akin ME, Demir P, Aydin G. An investigation of biomechanics, muscle performance, and disability level of craniocervical region of individuals with temporomandibular disorder. Cranio. 2024 Mar;42(2):232-242. doi: 10.1080/08869634.2021.1938854. Epub 2021 Jun 15.
7. Cocera Morata F, Rodríguez Blanco C. Relaciones entre la patología suboccipital y los trastornos temporomandibulares en el tratamiento osteopático. Osteopatía Científica. 2014;9(3):60-66.
6. Oliva Pascual-Vaca A, Rodríguez Blanco C. Sistema estomatognático, osteopatía y postura. Osteopatía Científica. 2008;3(2):88-90.
4. Hormiga Sánchez C, Bonet Collante M, Alodia Martínez C. Prevalencia de síntomas y signos de trastornos temporomandibulares en una población universitaria del área metropolitana de Bucamango, Santander. Umbral Científico, Bogotá Colombia. Junio de 2009: (14) 80-91.
2. Bermejo-Fenoll A. Desórdenes temporomandibulares. Madrid: Science Tools; 2008.
1. Rodríguez-Ozores Sánchez R. Mejorando la capacidad resolutiva. Patología de la Articulación Temporomandibular. Madrid, AMF, 2010: (6) 599-658.
Other Identifiers
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AMaCe-TB
Identifier Type: -
Identifier Source: org_study_id