Effectiveness of Neck Motor Control Exercises in Patients With Temporomandibular Disorders: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Fractional Anisotropy (FA)
研究概览
简要总结
Musculoskeletal (MSK) pain is a common reason to seek medical treatment. Temporomandibular disorders (TMDs) are MSK disorders that affect the masticatory muscles, the temporomandibular joint, and related structures in the neck and head. Current research showed that people with chronic TMDs have structural and functional brain changes that may contribute to chronic pain development and maintenance. Therapeutic exercise is a central component in treating chronic MSK conditions. New therapies, including exercise, appear to have potential in targeting cortical changes to improve clinical outcomes. However, mechanisms of action are not well understood, and evidence is limited to a few weak studies and specific populations. Evidence from our research group highlights neck exercise as potentially useful in treating TMDs. However, we do not yet know how the brains of women with TMD respond to specific exercise and whether these changes relate to decreased pain, improved function, and quality of life. Evidence linking brain plasticity, pain modulation, and exercise therapy is currently limited, and non-existent for people with TMDs. Objectives: In women with chronic TMD pain, we will:1) determine the impact of motor control training using visual feedback (MCTF) on clinical outcomes such as pain intensity and jaw disability, 2) assess the impact of MCTF on brain structure, using diffusion tensor imaging, 3) assess the impact of MCTF on brain networks, using resting state functional magnetic resonance imaging, and 4) determine the effectiveness of MCTF to restore normal muscular structure, performance and fatigability of neck cervical muscles, using electromyographic analysis. Methods: Women with chronic TMD pain will be randomized to either an intervention arm or a placebo control group. Women in the intervention arm will receive 8 weeks of progressive exercise MCTF of the cervical muscles, twice per week. Women in the placebo arm will receive innocuous transcutaneous electrical nerve stimulation (turn off). Our primary outcomes will be changes in 1) pain, measured with the Visual Analogue Scale, 2) brain structure and networks, measured by fractional anisotropy (brain structure) and the blood-oxygen-level dependent signal (brain networks). Outcomes will be measured at baseline, after 8 weeks of treatment, and 4 months after treatment ends. Results will directly inform and guide clinicians in prescribing more effective interventions for women with TMD
详细描述
To treat musculoskeletal disorders, looking at the brain is an unusual strategy but one with high potential for effectiveness. Exercise can potentially train the brain if we understand the links between exercise and productive changes in the brain. Given the high prevalence, impact, and burden of musculoskeletal disorders (MSKDs), therapies need to focus on the origin of the problem to be more effective and reduce economic costs. The latest evidence highlights the need for musculoskeletal rehabilitative therapy, including exercise, to look both at local structural and functional abnormalities of the MSK system and at alterations within the central nervous system. These central alterations have been shown to have a crucial role in the pathophysiology and clinical manifestations of MSKDs. People with chronic MSKDs show brain alterations such as decreased regional grey matter volume in brain areas such as the cingulate cortex, the insula, and the superior frontal and temporal gyrus. They also have impairments in pathways related to pain modulation. These brain alterations are visible in people with chronic MSKDs such as low back pain, osteoarthritis, headaches, and chronic temporomandibular disorders (TMDs).
Therapeutic exercise is a cornerstone for MSKD rehabilitation. Although its effects on pain are not fully understood, therapeutic exercise is widely applied in a variety of painful MSK conditions, including TMDs. Maladaptive changes in the motor cortex in MSKDs can improve after specific exercise training through motor control exercises and skilled cognitive practice, through strength and resistance training, and through novel motor training and visual feedback. However, all this evidence comes from preliminary studies with small sample sizes, before-and-after designs, and in specific clinical populations. Expanding this knowledge base to other clinical populations, with stronger study designs such as randomized controlled trials (RCTs), is important to accurately understand the effects of exercise therapy on brain plasticity and determine whether this approach is effective to manage MSKDs.
Our team is interested in managing TMDs through exercise therapy. From our previous studies on neck muscle impairment in people with TMDs and our recent update of a systematic review on therapeutic exercise to manage TMDs, we conclude that motor control exercise is a promising option to treat people with TMDs. However, the evidence is still limited and more high-quality investigations on the effectiveness of novel motor training in TMDs is needed.
OBJECTIVES
- Determine the impact of motor control training using visual feedback (MCTF) on pain-disability related outcomes such as pain intensity, pain pressure thresholds and jaw disability. We will compare outcomes for people with TMDs who receive MCTF or a placebo treatment after 8 weeks of treatment, and 4 months after treatment ends.
- Assess the impact of MCTF and explore its mechanisms of action on brain structure using DTI.
- Assess the impact of MCTF on brain networks using rsfMRI.
- Determine the effectiveness of MCTF in people with TMDs to restore normal muscular structure, performance and fatigability of the cervical muscles when compared with a placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients (reporting one of the main outcome for this study - pain) will be unaware of the hypothesis of this study and performance biases will be avoided by telling them that both treatment options have similar effectiveness. Assessors (measuring clinician assessed tests) and Statistician will be blinded to hypothesis and group allocation following established guidelines.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females 18-60 years of age (TMDs are more prevalent in females);
- •diagnosed with muscle pain disorders as classified by the new Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) or mixed TMD;
- •have had pain in the masticatory muscle for at least 3 months;
- •have chronic masticatory muscle pain not attributable to recent acute trauma, previous infection, or active inflammation; and
- •have a moderate or severe baseline pain score of 30 mm or greater using a 100 mm VAS.
排除标准
- •metabolic, rheumatoid, or vascular diseases;
- •commonly comorbid functional chronic pain disorders (e.g., irritable bowel syndrome, fibromyalgia);
- •psychiatric disorders (e.g., depression, schizophrenia);
- •abnormal neurological examination;
- •contraindication for MRI scanning (e.g., metallic surgical implant);
- •self-report of substance abuse;
- •exercise therapy in the 6 months before entry into the study or current treatment for TMD;
- •previous experience with electrotherapy; or
- •pregnant or planning a pregnancy.
- •After confirming eligibility to participate in the study, all participants will be asked to sign an informed consent in accordance with the UofA´s policies on research using human participants.
结局指标
主要结局
Fractional Anisotropy (FA)
时间窗: Change from baseline at 2 months (change from baseline at 6 months (if budget allows))
To analyze the DTI images, we will use a method similar to Moayedi et al. To analyze the rsfMRI images, we will use the pipeline outlined in Greicius et al.in addition to applying functional connectivity (graphical modelling) as previously used in our lab. Images will be imported into the software library (FSL v. 4.1.8) of the Oxford Centre for Functional MRI of the Brain (FMRIB). Preprocessing will include current and motion artifact correction using the FMRIB Diffusion Toolbox v. 2.0. The DTI images will be processed through 2 different pipelines for 1) voxel-wise analysis and 2) tractography. The preprocessed images will be fit with a diffusion tensor model using DTIFIT in the FDT. We then will calculate voxel-wise values of FA. The rsfMRI images will be analyzed using an ICA approach to isolate the DMN and the sensorimotor network and a functional connectivity approach using graphical modelling to assess the neural networks associated with TMD treatment.
Pain Intensity measured with a Visual Analogue Scale (VAS)
时间窗: Change from baseline at 2 months ( change from baseline at 6 months )
The VAS is a linear scale 10 cm in length, labeled with the two extremes boundaries of pain sensation: "no pain", at one end and "worst pain imaginable" at the other end. The validity and reliability of these methods for determining pain intensity, has been reported and confirmed in the literature
functional brain networks
时间窗: Change from baseline at 2 months (change from baseline at 6 months (if budget allows))
To analyze the DTI images, we will use a method similar to Moayedi et al. To analyze the rsfMRI images, we will use the pipeline outlined in Greicius et al.in addition to applying functional connectivity (graphical modelling) as previously used in our lab. Images will be imported into the software library (FSL v. 4.1.8) of the Oxford Centre for Functional MRI of the Brain (FMRIB). Preprocessing will include current and motion artifact correction using the FMRIB Diffusion Toolbox v. 2.0. The DTI images will be processed through 2 different pipelines for 1) voxel-wise analysis and 2) tractography. The preprocessed images will be fit with a diffusion tensor model using DTIFIT in the FDT. We then will calculate voxel-wise values of FA. The rsfMRI images will be analyzed using an ICA approach to isolate the DMN and the sensorimotor network and a functional connectivity approach using graphical modelling to assess the neural networks associated with TMD treatment.
次要结局
- Global Rating Scale (GRS)(Change from baseline at 2 months ( change from baseline at 6 months ))
- Jaw function(Change from baseline at 2 months ( change from baseline at 6 months ))
- Psychological functioning: distress(Change from baseline at 2 months ( change from baseline at 6 months ))
- Neck Flexor Endurance Test(Change from baseline at 2 months ( change from baseline at 6 months ))
- Neck Extensor Endurance Test:(Change from baseline at 2 months ( change from baseline at 6 months ))
- Craniocervical Flexion Test (CCFT)(Change from baseline at 2 months ( change from baseline at 6 months ))
- Pressure Pain Threshold (PPT)(Change from baseline at 2 months ( change from baseline at 6 months ))
- The Neck Disability Index(Change from baseline at 2 months ( change from baseline at 6 months ))
- Muscle structure(Change from baseline at 2 months ( change from baseline at 6 months ))
- Psychological functioning: anxiety(Change from baseline at 2 months ( change from baseline at 6 months ))
- Psychological functioning: depression(Change from baseline at 2 months ( change from baseline at 6 months ))
- level of expectations(baseline)
- therapeutic alliance(at 2 months)