Zhang Qi, Zhang Juan, Ran Wenjing, Yu Shuipeng, Jin Yingshu
School of Nursing, Tianjin University of Traditional Chinese Medicine.
The TMJ Clinic, Stomatological Hospital of Tianjin Medical University.
Medicine (Baltimore). 2020 Nov 20;99(47):e23295. doi: 10.1097/MD.0000000000023295.
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.
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).
This study protocol reported a randomized controlled trial which aimed at assessing the effectiveness of the CBT versus conventional treatment with TMD.
Registered in the Chinese Clinical Trial Registration Center with the number ChiCTR2000038573. Registered 24 September 2020.
颞下颌关节紊乱病（TMD）是口腔科常见的身心疾病。疼痛和下颌运动受限是患者寻求口腔治疗的主要原因。然而，由于存在运动恐惧，患者常将疼痛灾难化，从而避免下颌运动，严重影响其生活质量。认知行为疗法（CBT）在改善肌肉骨骼疾病患者的运动恐惧和生活质量方面有显著效果，但在TMD患者中尚未得到证实。本研究旨在将CBT应用于TMD患者的运动恐惧及口腔健康相关生活质量（OHRQOL）。
共有108名年龄在18至65岁之间、将被转诊至中国天津医科大学口腔医院颞下颌关节门诊的患者被随机分为2个治疗组。对照组接受常规治疗，而实验组在对照组的基础上接受CBT。主要结局指标为运动恐惧和OHRQOL，分别采用颞下颌关节紊乱病患者运动恐惧坦帕量表（TSK-TMD）和颞下颌关节紊乱病患者口腔健康影响量表（OHIP-TMDs）进行测量；次要结局指标包括采用数字评定量表（NRS）测量的疼痛强度、采用疼痛灾难化量表（PCS）测量的疼痛灾难化、采用医院焦虑抑郁量表（HADS）测量的焦虑和抑郁，以及采用一般自我效能感量表（GSES）测量的自我效能感。
本研究方案报告了一项随机对照试验，旨在评估CBT对比TMD常规治疗的有效性。
在中国临床试验注册中心注册，注册号为ChiCTR2000038573。于2020年9月24日注册。
