What Are the Clinical Factors Associated With a Significant Pain Reduction Following Physiotherapy in Patients With Temporomandibular Disorders?

Istituto Stomatologico Italiano

Status

Completed

Conditions

Temporomandibular Disorders

Treatments

Other: Physiotherapy - Manual Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT03990662

PredictorsOutcomeTMD2019GA

Details and patient eligibility

About

RATIONALE OF THE OBSERVATION STUDY:

This study aims to observe which patients with temporomandibular disorder improve more following a physiotherapy program of four sessions. Knowing the characteristics of patients who have the most significant improvements could help clinician advise or advise against physiotherapy for the treatment of temporomandibular disorders.

STUDY PROCEDURES The study will be conducted at the Istituto Stomatologico Italiano. Patients diagnosed with Temporomandibular Disorder will be recruited in the gnathological and neuromuscular gnathological departments. The physiotherapists of the Craniomandibular Physiotherapy Service will perform physiotherapy therapy, which consists of four physiotherapy sessions [lasting 30 minutes, about once a week] over a month. Before starting the treatment, participants will be asked to answer some questions concerning their state of health (e.g. pain intensity) with particular reference to Temporomandibular Disorder (e.g. location and duration of pain). The intensity of pain and the level of function will then be monitored at baseline, after 4 weeks and after 8 weeks from baseline.

EXPECTED BENEFITS FROM THE STUDY AND EXPECTED BENEFITS FOR THE PATIENT The benefits are the discovery of new knowledge in the field of therapeutic choice for patients with temporomandibular disorder.

Full description

Additional information:

In this study protocol, the variables reported in the section "Other Pre-specified Outcomes" are the predictors that will be included in the prediction model.

The total "Enrollment" is 180 participants (100 for the development phase and 80 for the validation phase).

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(1) adults aged ≥18 years;
(2) TMD diagnosis according to the Axis I of the Diagnostic Criteria for TMDs (DC/TMD) (Shiffman et al., 2014);
(3) no therapeutic interventions reported (for their TMD) in the past six months (Wahlund et al., 2015);
(4) capacity to use and understand written and verbal Italian language;
(5) mental capacity to provide informed consent.

Exclusion criteria

(1) TMD pain related to rheumatoid/inflammatory arthritis;
(2) any physical or mental condition that could potentially influence the study;
(3) they commence another treatment for their TMD (pharmacology, oral appliance, others) throughout the duration of the study.