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Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT03726060
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Pillastrini, University of Bologna

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Other: control group Other: test group Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : October 29, 2020
Estimated Study Completion Date : October 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 3 months.

Other: control group
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
Other Name: splint therapy

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.

Other: test group
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
Other Name: splint therapy with physical therapy




Primary Outcome Measures :
  1. Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain [ Time Frame: Change from initial VAS at 3 and 6 months from the beginning of the treatment ]
    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


Secondary Outcome Measures :
  1. ROM (range of motion) [ Time Frame: The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment ]

    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)


  2. Psychosocial factors with questionnaire of Hospital Anxiety and Depression Scale [ Time Frame: The questionnaire is administered at the recruitment then at 3 and 6 months from the beginning of the treatment ]
    HADS (Hospital Anxiety and Depression Scale) is a questionnaire used to identify the presence of anxiety and depression in people with non-psychiatric health problems. It is divided into two subscales, one on anxiety (HADS-A) and one on depression (HADS-D), each containing seven mixed items. Each item is rated on a scale from 0 to 3, with a maximum score of 11 for each subscale. A score of 11 or more indicates a significant case of psychiatric comorbidity, a score of 8-10 means the presence of a disorder, a score of 7 or less is considered normal8.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726060


Contacts
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Contact: Paolo Pillastrini 0512142496 paolo.pillastrini@unibo.it

Locations
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Italy
University of Bologna Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Contact: Claudio Marchetti, Laurea    +39 0512088 ext 157    claudio.marchetti@unibo.it   
Sub-Investigator: Paolo Pillastrini         
Principal Investigator: Claudio Marchetti         
Sub-Investigator: Adele Fabrizi         
Sub-Investigator: Antonio Romeo         
Sponsors and Collaborators
Paolo Pillastrini

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Responsible Party: Paolo Pillastrini, professor, University of Bologna
ClinicalTrials.gov Identifier: NCT03726060     History of Changes
Other Study ID Numbers: 47/2018/SPER/AUSLBO
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes