Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

NCT ID: NCT03726060

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2022-01-31

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.

Conditions

Temporomandibular Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

control group

Intervention Type: OTHER

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

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.

Group Type: OTHER

test group

Intervention Type: OTHER

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

Interventions

control group

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

splint therapy; splint therapy with physical therapy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paolo Pillastrini

OTHER

Sponsor Role: lead

Responsible Party

Paolo Pillastrini

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Bologna

Bologna, Emilia-Romagna, Italy

Countries

Italy

References

Romeo A, Incorvati C, Vanti C, Turolla A, Marinelli F, Defila L, Gulotta C, Marchetti C, Pillastrini P. Physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: A randomised controlled trial. J Oral Rehabil. 2024 Aug;51(8):1566-1578. doi: 10.1111/joor.13729. Epub 2024 May 17.

Reference Type: DERIVED

PMID: 38757854 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32792449 (View on PubMed)

Other Identifiers

47/2018/SPER/AUSLBO

Identifier Type: -

Identifier Source: org_study_id