Effectiveness of cognitive behavioral therapy on kinesiophobia and oral health-related quality of life in patients with temporomandibular disorders, study protocol for a randomized controlled trial

Abstract Background: Temporomandibular disorders (TMD) is a common physical and psychological disease in dental department. Pain and mandibular limitation are the main reasons for patients to seek oral treatment. However, the presence of kinesiophobia, patients often catastrophize pain, so as to avoid mandibular movement, which seriously affects their quality of life. Cognitive behavioral therapy (CBT) has significant improvements in reducing kinesiophobia and quality of life in musculoskeletal disease, but has not been proved in TMD patients. The study aims to apply CBT on kinesiophobia and oral health related quality of life (OHRQOL) in TMD patients. Methods: A total of 108 individuals between 18 and 65 years of age, who will be referred to the temporomandibular joint clinic of Stomatology Hospital of Tianjin Medical University in china will be randomized into 2 treatment arms. The control group will receive a conventional treatment, whereas the experiment group will receive CBT on the basis of the control group. The primary outcomes will be the kinesiophobia and OHRQOL, and will be measured by the Tampa scale for kinesiophobia for patients with Temporomandibular Disorders (TSK-TMD) and the Oral Health Impact Scale for patients with temporomandibular disorders (OHIP-TMDs), the secondary outcomes will be pain intensity measured by Numerical Rating Scale (NRS), pain catastrophizing measured by Pain Catastrophizing Scale (PCS), anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS), and self-efficacy measured by General Self-Efficacy Scale (GSES). Discussion: This study protocol reported a randomized controlled trial which aimed at assessing the effectiveness of the CBT versus conventional treatment with TMD. Trial registration: Registered in the Chinese Clinical Trial Registration Center with the number ChiCTR2000038573. Registered 24 September 2020.