Effect of Active Mandibular Techniques and Specific Cranio-cervical Therapeutic Exercise in Patients With Temporomandibular Disorders and Bruxism (AMaCe-TB)

NCT07303361 | Completed

• 1 other identifier: AMaCe-TB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular Disorders (TMD) are a common source of pain and functional limitation affecting the stomatognathic system. They frequently lead to difficulties in mastication, decreased quality of sleep, limited mandibular mobility, and restrictions in daily activities. These symptoms are often aggravated in patients with associated bruxism. Chronic involvement of the temporomandibular joint and surrounding structures can also negatively influence cervical posture and motor control due to the neurophysiological connections between the cranio-cervical region and mandibular biomechanics. This study is designed to evaluate whether active mandibular techniques, specifically the Muscle Energy Technique (MET) applied with the support of the jaw motion rehabilitation system, combined with a cranio-cervical therapeutic exercise program, may improve pain, function, and motor behavior in patients with chronic TMD and bruxism. 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.

Conditions

Temporomandibular Disorder (TMD)

Keywords

temporomandibular disorder; bruxism; pain control

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold (PPT / UDP)

  The primary outcome will be the change in pressure pain threshold (PPT), also referred to as Umbral de Dolor a la Presión (UDP), measured in kg/cm² using a handheld pressure algometer at clinically relevant trigger points of the upper trapezius, masseter, external pterygoid, and digastric muscles. An increase in PPT indicates improved pain sensitivity. The objective is to determine whether the mandibular muscle energy technique combined with cranio-cervical control exercise leads to superior improvements compared to standard care and placebo suboccipital inhibition techniques

  After 4-week intervention and 12 week follow up.

Secondary Outcomes (7)

• Maximum Mouth Opening (MMO)

  Baseline, after 4-week intervention, 12 week follow up.

• Pain Intensity

  Baseline, after 4-week intervention and at 12 week follow up.

• Craniocervical Postural Control

  Baseline, after 4-week intervention and at 12 week follow up.

• Mandibular Range of Motion

  Baseline, after 4-week intervention and at 12 week follow up.

• Myofascial Trigger Point Sensitivity

  Baseline, after 4-week intervention and at 12 week follow up.

Study Arms (2)

Specific technique Group

EXPERIMENTAL

Patients will undergo the mandibular muscle energy technique, as well as specific craniocervical motor control exercises.

Procedure: Mandibular Muscle Energy Technique

Stardard clinical treated group

PLACEBO COMPARATOR

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.

Procedure: Modified suboccipital inhibition technique

Interventions

Mandibular Muscle Energy Technique PROCEDURE

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.

Specific technique Group

Modified suboccipital inhibition technique PROCEDURE

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.

Stardard clinical treated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years.
• 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.

You may not qualify if:

• Previous surgery or major trauma to the cervical or maxillofacial area.
• 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.

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead
• Gerencia Regional de Salud de Castilla y Leon: collaborator

Study Sites (1)

Complejo Asistencial Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Related Publications (19)

• 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.

  PMID: 19243721 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20114099 BACKGROUND

• 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.

  PMID: 11753327 BACKGROUND

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  PMID: 20510644 BACKGROUND

• 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.

  BACKGROUND

• Dworkin SF, LeResche L, Von Korff MR. Diagnostic studies of temporomandibular disorders: challenges from an epidemiologic perspective. Anesth Prog. 1990 Mar-Jun;37(2-3):147-54.

  PMID: 2085194 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19447262 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26294683 BACKGROUND

• 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.

  PMID: 20524969 BACKGROUND

• 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.

  PMID: 34128775 BACKGROUND

• 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.

  BACKGROUND

• 6. Oliva Pascual-Vaca A, Rodríguez Blanco C. Sistema estomatognático, osteopatía y postura. Osteopatía Científica. 2008;3(2):88-90.

  BACKGROUND

• 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.

  BACKGROUND

• 2. Bermejo-Fenoll A. Desórdenes temporomandibulares. Madrid: Science Tools; 2008.

  BACKGROUND

• 1. Rodríguez-Ozores Sánchez R. Mejorando la capacidad resolutiva. Patología de la Articulación Temporomandibular. Madrid, AMF, 2010: (6) 599-658.

  BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism; Agnosia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Márquez Vera, PhD

  Centro Asistencial Universitario de Salamanca (CAUSA)

  PRINCIPAL INVESTIGATOR

• Jose Antonio Blanco Rueda, MD, PhD

  Centro Asistencial Universitario de Salamanca (CAUSA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 24, 2025
• Study Start: November 22, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 31, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

ES (1)