Clinical trial NCT03990662: What Are the Clinical Factors Associated With a Significant Pain Reduction Following Physiotherapy in Patients With Temporomandibular Disorders?
Official title: Predictors of Good Outcomes Following Manual Therapy in Patients With Temporomandibular Disorders: Development and Validation Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorders
Keywords: Temporomandibular Joint Dysfunction Syndrome
Manual Therapy
Prediction
Pain
Lead sponsor: Istituto Stomatologico Italiano
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2019-06-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited in a Dental Hospital \[TMJ Unit\].

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Intensity (Visual Analogue Scale [VAS]) from baseline to one month
timeFrame: Change from baseline to one month
measure: Change in Pain Intensity (Visual Analogue Scale [VAS]) from baseline to two month
timeFrame: Change from baseline to two month
measure: Change in Function (patient specific functional scale [PSFS]) from baseline to one month
timeFrame: Change from baseline to one month
measure: Change in Function (patient specific functional scale [PSFS]) from baseline to two month
timeFrame: Change from baseline to two month
Secondary outcomes:
Other outcomes:
measure: Pain during maximal mouth opening
timeFrame: Baseline, one month, two months
measure: Central sensitisation: Central Sensitisation Inventory (CSI)
timeFrame: Baseline
measure: Treatment expectations
timeFrame: Baseline
measure: Duration of TMD pain
timeFrame: Baseline
measure: Maximal mouth opening (MMO)
timeFrame: Basiline, one month, two months
measure: Number of pain locations
timeFrame: Baseline
Locations:
city: Miano
country: Italy
facility: Istituto Stomatologico Italiano
state: Milano
Study officials:
affiliation: Istituto Stomatologico Italiano
name: Giacomo Asquini
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asquini G, Devecchi V, Borromeo G, Viscuso D, Morato F, Locatelli M, Falla D. Predictors of pain reduction following a program of manual therapies for patients with temporomandibular disorders: A prospective observational study. Musculoskelet Sci Pract. 2022 Dec;62:102634. doi: 10.1016/j.msksp.2022.102634. Epub 2022 Jul 31.
citation: Asquini G, Bianchi AE, Borromeo G, Locatelli M, Falla D. The impact of Covid-19-related distress on general health, oral behaviour, psychosocial features, disability and pain intensity in a cohort of Italian patients with temporomandibular disorders. PLoS One. 2021 Feb 2;16(2):e0245999. doi: 10.1371/journal.pone.0245999. eCollection 2021.
citation: Asquini G, Bianchi AE, Heneghan NR, Rushton AB, Borromeo G, Locatelli M, Falla D. Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study. BMJ Open. 2019 Nov 12;9(11):e032113. doi: 10.1136/bmjopen-2019-032113.