Clinical trial NCT03726060: Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
Official title: Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
timeFrame: Change from initial VAS at 3 and 6 months from the beginning of the treatment
Secondary outcomes:
measure: ROM (range of motion)
timeFrame: The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: Emilia-Romagna
Study officials:
References:
citation: Incorvati C, Romeo A, Fabrizi A, Defila L, Vanti C, Gatto MRA, Marchetti C, Pillastrini P. Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e038438. doi: 10.1136/bmjopen-2020-038438.