External validation of a clinical prediction tool for the use of manual therapy for patients with temporomandibular disorders: a protocol for a prospective observational study.

INTRODUCTION: Clinical guidelines recommend conservative treatment for the management of temporomandibular disorders (TMD), and manual therapy directed to temporomandibular structures is commonly applied to reduce pain and improve function. In a recent prospective study, we developed a clinical prediction tool based on an array of predictors to identify people with TMD who are likely to experience significant pain relief and functional improvements following a programme of manual therapies (MTP) applied to temporomandibular structures. The purpose of this study is to externally validate in a different sample (temporal validation) the prediction model obtained in the initial study. METHODS/ANALYSIS: This observational prospective study will recruit a cohort of 120 adults with TMD from a Dental Hospital in Italy. The intervention will be an MTP consisting of four sessions (once per week) of manual therapy applied to temporomandibular structures. Candidate predictors included in the predictive model will be pain intensity during mouth opening, treatment expectations, number of pain locations, central sensitisation, TMD pain duration and maximal mouth opening. Outcome measures (i.e., pain intensity, functional improvement) will be collected before starting the MTP, after the last session and after 1 month (2 months from baseline). A reduction of pain intensity by at least 30% will be considered a good outcome. External validity of the prediction model will be evaluated after the last session by measuring its calibration, discrimination and overall fit. Additionally, the performance of the model will be evaluated considering the clinical outcomes collected 1 month after the last MTP session. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Ethics Committee of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy. The results will be submitted for publication in a peer-reviewed journal, and the prediction model will be implemented in a web-based calculator to facilitate its use by clinicians. TRIAL REGISTRATION NUMBER: NCT03990662.

Predictors of pain reduction following a program of manual therapies for patients with temporomandibular disorders: A prospective observational study.

BACKGROUND: Clinical guidelines recommend conservative treatment for the management of temporomandibular disorders (TMD), and manual therapy (MT) is commonly applied to reduce pain and improve function. OBJECTIVES: To identify predictors of pain reduction and functional improvement following a program of manual therapies (MTP) in patients with TMD and develop a first screening tool that could be used in clinical practice to facilitate decision-making. DESIGN: A cohort of 102 adults with a diagnosis of TMD were treated with four weekly sessions within a MTP applied to craniomandibular structures. Candidate predictors were demographic variables, general health variables, psychosocial features, TMD characteristics and related clinical tests. A reduction of pain intensity by at least 30% after the MTP was considered a good outcome. Logistic regression was adopted to develop the predictive model and its performance was assessed considering the explained variance, calibration, and discrimination. Internal validation of the prediction models was further evaluated in 500 bootstrapped samples. RESULTS: Patients experiencing pain intensity greater than 2/10 during mouth opening, positive expectations of outcome following a MTP, pain localized in the craniocervical region, and a low Central Sensitization Inventory score obtained a good outcome following the MTP. Predictive performance of the identified physical and psychological variables was characterized by high explained variance (R2 = 58%) and discrimination (AUC = 89%) after internal validation. A preliminary screening clinical tool was developed and presented as a nomogram. CONCLUSIONS: The high discrimination of the prediction model revealed promising findings, although these need to be externally validated in future research. TRIAL REGISTRATION NUMBER: NCT03990662.

Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review.

BACKGROUND: Within physical therapy, manual therapy is known to be effective for managing temporomandibular disorders (TMDs). However, manual therapy is a broad term including different approaches applied to different body regions. AIMS: This is the first systematic review that aims to evaluate the effectiveness of manual therapy applied specifically to the craniomandibular structures (Cranio-Mandibular Manual Therapy [CMMT]) on pain and maximum mouth opening in people with TMD. MATERIAL AND METHODS: This systematic review was developed based on a pre-determined published protocol which was prospectively registered with PROSPERO (CRD42019160213). A search of MEDLINE, Embase, CINAHL, ZETOC, Web of Science, SCOPUS, PEDro, PubMed, Cochrane Library and Best Evidence, EBM reviews-Cochrane Central Register of Controlled Trials, Index to Chiropractic Literature ChiroAccess and Google Scholar databases was conducted from inception until October 2020. Randomised controlled trials comparing the effect of CMMT on pain and maximum mouth opening versus other types of treatment in TMDs were included. Two reviewers independently screened articles for inclusion, extracted data, assessed risk of bias with the revised Cochrane risk of bias tool for randomised trials and evaluated the overall quality of evidence with the Grading of Recommendations, Assessment, Development and Evaluations. RESULTS: A total of 2720 records were screened, of which only 6 (293 participants) satisfied the inclusion criteria. All studies showed some concerns in risk of bias, except for one, which was high risk of bias. The overall quality of evidence was very low for all outcomes because of high heterogeneity and small sample sizes. All studies showed a significant improvement in pain and maximum mouth opening for CMMT from baseline in the mid-term, but only two showed superiority compared to other interventions. Given the high heterogeneity and small sample sizes of the included studies, a quantitative synthesis was not performed. DISCUSSION AND CONCLUSION: There is the need for future high methodology research investigating different manual therapy techniques applied to different regions and different populations (e.g., chronic versus acute TMD) to determine what is most effective for pain and maximum mouth opening in patients with TMDs.

The effectiveness of manual therapy applied to craniomandibular structures in the treatment of temporomandibular disorders: protocol for a systematic review.

BACKGROUND: The term temporomandibular disorder (TMD) includes disorders of the temporomandibular joints (TMJ), masticatory muscles and adjacent tissues. Several studies have examined the effectiveness of manual therapy (MT) for TMDs by evaluating changes in pain and maximum mouth opening (MMO). Nevertheless, the effectiveness of MT exclusively applied to the craniomandibular structures (craniomandibular manual therapy (CMMT)) on pain and TMJ range of motion remains unclear. This review aims to evaluate the effectiveness of CMMT on pain and TMJ range of motion in people with TMDs. METHODS: This protocol is reported in line with the preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P). Databases including MEDLINE, Embase, CINAHL, ZETOC, Web of Science, SCOPUS, PEDro, PubMed, Cochrane Library and Best Evidence, EBM reviews-Cochrane Central Register of Controlled Trials, Index to Chiropractic Literature ChiroAccess and Google Scholar will be searched from inception as well as key journals and grey literature. Randomised controlled trials involving adults with TMD that compare the effect of any type of CMMT (e.g. mobilisation) on pain and range of motion with a placebo intervention, controlled care intervention or other types of treatment will be included. Two reviewers will independently screen articles for inclusion, extract data, assess risk of bias (revised Cochrane risk of bias tool) for included studies and evaluate overall quality of evidence (Grading of Recommendations Assessment, Development and Evaluation). A meta-analysis will be conducted if possible. If not, a narrative synthesis will be conducted reporting the effectiveness of CMMT according to disorder type (TMJ disorders, masticatory muscle disorders and mixed disorders). DISCUSSION: In this review, the effectiveness of MT applied to craniomandibular structures for the treatment of TMD will be evaluated. Results will be submitted for publication in a peer-reviewed journal and presented at conferences. We expect our findings will facilitate treatment planning for manual therapists managing patients with TMD and provide future clinical research implications. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019160213.

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 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.