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

Abstract

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.