Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study

Introduction Temporomandibular disorders (TMDs) are principally characterised by pain in the craniomandibular area and probable limitations of jaw opening. Manual therapy, like other recommended conservative treatments included in clinical guidelines, is commonly used to treat patients with TMD to r...

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Main Authors: Alison B Rushton, Nicola R Heneghan, Deborah Falla, Giacomo Asquini, Andrea Edoardo Bianchi, Giulia Borromeo, Matteo Locatelli
Format: Article
Language:English
Published: BMJ Publishing Group 2019-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/11/e032113.full
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author Alison B Rushton
Nicola R Heneghan
Deborah Falla
Giacomo Asquini
Andrea Edoardo Bianchi
Giulia Borromeo
Matteo Locatelli
author_facet Alison B Rushton
Nicola R Heneghan
Deborah Falla
Giacomo Asquini
Andrea Edoardo Bianchi
Giulia Borromeo
Matteo Locatelli
author_sort Alison B Rushton
collection DOAJ
description Introduction Temporomandibular disorders (TMDs) are principally characterised by pain in the craniomandibular area and probable limitations of jaw opening. Manual therapy, like other recommended conservative treatments included in clinical guidelines, is commonly used to treat patients with TMD to reduce pain and improve function. However, outcomes may be variable. The aim of this study is to identify predictors associated with pain reduction in patients with TMD following manual therapy by analysing a combination of patient-reported outcome measures and clinical tests. Such knowledge will support a more personalised management approach by facilitating clinical decision-making.Methods/analysis An observational prospective design will recruit a cohort of 100 adults with a diagnosis of TMD (according to Axis I of the Diagnostic Criteria for TMD) at a Dental Hospital in Italy. Patients will be treated with four weekly sessions of manual therapy applied to craniomandibular structures. An array of predictors has been chosen based on previous research on prognostic factors for TMD and altered pain modulation in musculoskeletal disorders. Candidate predictors including demographic variables, general health variables, psychosocial features, TMD characteristics and clinical tests of the temporomandibular joint and masticatory muscles will be collected at baseline. Definition of good outcome is a clinically significant reduction of pain intensity over the last week (≥30% reduction Visual Analogue Scale) immediately following the four week intervention. Exploratory factor analysis will be applied to analyse factor loading of candidate predictors for good outcome at four weeks. Subsequently, a logistic multivariable regression model will be performed to calculate low and high risk of good outcome.Ethics and dissemination Ethical approval has been obtained from the ‘Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico’ and University of Birmingham Ethics Committee. The results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registration number NCT03990662; Pre-results.
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spelling doaj-art-a21b9c80b9a24d1ca67f63bd6949f7212024-11-29T14:20:08ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-032113Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational studyAlison B Rushton0Nicola R Heneghan1Deborah Falla2Giacomo Asquini3Andrea Edoardo Bianchi4Giulia Borromeo5Matteo Locatelli6School of Physical Therapy, Western University Faculty of Health Sciences, London, Ontario, CanadaCentre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham,Edgbaston, Birmingham, UKCentre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sports, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK1 University of Birmingham, Birmingham, UKDepartment of Craniomandibular Disorders, Italian Stomatologic Institute, Milan, ItalyCraniomandibular Physiotherapy Service, Istituto Stomatologico Italiano, Milano, ItalyDepartment of Rehabilitation and Functional Recovery, IRCCS San Raffaele Scientific Institute, Milan, ItalyIntroduction Temporomandibular disorders (TMDs) are principally characterised by pain in the craniomandibular area and probable limitations of jaw opening. Manual therapy, like other recommended conservative treatments included in clinical guidelines, is commonly used to treat patients with TMD to reduce pain and improve function. However, outcomes may be variable. The aim of this study is to identify predictors associated with pain reduction in patients with TMD following manual therapy by analysing a combination of patient-reported outcome measures and clinical tests. Such knowledge will support a more personalised management approach by facilitating clinical decision-making.Methods/analysis An observational prospective design will recruit a cohort of 100 adults with a diagnosis of TMD (according to Axis I of the Diagnostic Criteria for TMD) at a Dental Hospital in Italy. Patients will be treated with four weekly sessions of manual therapy applied to craniomandibular structures. An array of predictors has been chosen based on previous research on prognostic factors for TMD and altered pain modulation in musculoskeletal disorders. Candidate predictors including demographic variables, general health variables, psychosocial features, TMD characteristics and clinical tests of the temporomandibular joint and masticatory muscles will be collected at baseline. Definition of good outcome is a clinically significant reduction of pain intensity over the last week (≥30% reduction Visual Analogue Scale) immediately following the four week intervention. Exploratory factor analysis will be applied to analyse factor loading of candidate predictors for good outcome at four weeks. Subsequently, a logistic multivariable regression model will be performed to calculate low and high risk of good outcome.Ethics and dissemination Ethical approval has been obtained from the ‘Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico’ and University of Birmingham Ethics Committee. The results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registration number NCT03990662; Pre-results.https://bmjopen.bmj.com/content/9/11/e032113.full
spellingShingle Alison B Rushton
Nicola R Heneghan
Deborah Falla
Giacomo Asquini
Andrea Edoardo Bianchi
Giulia Borromeo
Matteo Locatelli
Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study
BMJ Open
title Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study
title_full Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study
title_fullStr Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study
title_full_unstemmed Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study
title_short Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study
title_sort predictors of pain reduction following manual therapy in patients with temporomandibular disorders a protocol for a prospective observational study
url https://bmjopen.bmj.com/content/9/11/e032113.full
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