Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.
They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).
The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Randomized controlled clinical trial with randomization according to a multi-phase design.
Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.
Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.
Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.
The 2 therapeutic protocols are:
- gnathological therapy (splint) associated with education and physiotherapy (test group);
- gnathological therapy (splint) associated with education (control group). During the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code.
The code consists of a progressive number followed by the patient's initials (eg 01-F.R.).
Subsequently, the patients will be randomized blinded and assigned to one of the two study groups.
Randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator.
Both types of treatment will be performed by a single operator respectively.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italia, 40138
- University of Bologna
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;
- patients older than 18 years;
- good knowledge of Italian language;
- patients who have signed informed consent
Exclusion Criteria:
- edentulism which makes it impossible to apply gnathological bite;
- patients with psychiatric problems;
- patients included in other experimental protocols;
- patients already undergoing surgical and / or radial therapy of the cervical and facial areas;
- other temporomandibular disorders without a myogenic component;
- treatment of the cervical and TMJ district in the previous 3 months;
- history of drug abuse.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: splint therapy
Alginate impressions will be taken and the plaster models of the dental arches will be made. The splint will be subsequently delivered to the patient with the relative indications of use. The splint therapy consist in the use of neuromuscoral splint every the night for 6 months. |
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
Otros nombres:
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Otro: physical therapy with splint therapy
The treatment consists of a series of interventions: advice on self-treatment techniques to be performed at home and administering manual therapy techniques addressed to: temporomandibular district, cervical and cervico-thoracic junction. Each session will be carried out individually and will last for 45 minutes. This duration will be divided as follows: 25 minutes dedicated to the temporomandibular district, 15 minutes to the cervical and cervico-thoracic junction, 5 minutes to teaching self-treatment techniques to be carried out at home and to verify the correct way of performing them. The cycle will consist of 10 sessions distributed over 3 months. |
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
Periodo de tiempo: Change from initial VAS at 3 and 6 months from the beginning of the treatment
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The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10.
The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing
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Change from initial VAS at 3 and 6 months from the beginning of the treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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ROM (range of motion)
Periodo de tiempo: The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
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The ROM measures the joint function. It provides the analytical and millimetric measurement of functional movements with a precision gauge positioned between the incisal edges of the upper and lower anterior groups. It should be noted: maximum buccal opening; deviation of the median line; left and right lateral movements; overjet and overbite. It should also be noted the extent of final elasticity (or end-feel test and its nature (elastic, painful, hard) |
The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Enfermedades Estomatognáticas
- Enfermedades de la mandíbula
- Trastornos Craneomandibulares
- Enfermedades mandibulares
- Síndromes de dolor miofascial
- Trastornos de la articulación temporomandibular
- Síndrome de disfunción de la articulación temporomandibular
Otros números de identificación del estudio
- 47/2018/SPER/AUSLBO
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Trastorno Temporomandibular
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TC Erciyes UniversityReclutamientoTrastornos de la articulación temporomandibular | Trastorno Temporomandibular | Dolor en la articulación temporomandibular | Artrosis de la articulación temporomandibular | Derrame de la articulación temporomandibularPavo
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Wroclaw Medical UniversityInscripción por invitaciónTrastornos de la articulación temporomandibular | Trastorno Temporomandibular | Artrosis de la articulación temporomandibular | Artritis TemporomandibularPolonia
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University of Nove de JulhoDesconocidoTrastorno TemporomandibularBrasil
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Karolinska InstitutetUniversity of Oslo; University of BergenTerminadoTrastornos de la articulación temporomandibular | Desplazamiento del disco de la articulación temporomandibular | Artrosis de la articulación temporomandibular | Artritis TemporomandibularSuecia
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Hacettepe UniversityThe Scientific and Technological Research Council of TurkeyReclutamientoTrastornos de la articulación temporomandibular | Síndrome de disfunción de la articulación temporomandibular | Trastorno Temporomandibular | Dolor en la articulación temporomandibular | Terapia manual | Desplazamiento del disco de la articulación temporomandibularPavo
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Assiut UniversityTerminadoTrastorno TemporomandibularEgipto
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Turkoglu Dr. Kemal Beyazit State HospitalTerminadoBruxismo | Dolor miofascial | Trastorno TemporomandibularPavo
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Riphah International UniversityTerminadoDisfunción de la articulación temporomandibular | Articulación temporomandibularPakistán
-
University of ValenciaTerminadoDisfunción Temporomandibular (DTM)España
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University of Nove de JulhoTerminadoTrastorno Temporomandibular
Ensayos clínicos sobre control group
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University of LisbonAssociacao Protectora dos Diabeticos de PortugalTerminado
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Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos
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University of Sao Paulo General HospitalTRB ChemedicaTerminadoOsteoartritis | Osteoartritis de rodillaBrasil
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Aydin Adnan Menderes UniversityAún no reclutando
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