NCT03726060

Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Paolo Pillastrini · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Temporomandibular Disorder

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2018-10-31
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2018-10-31
• Last updated: 2022-05-31

Locations

1 site across 1 country: Italy