Investigation of the Relationship Between Surgical Approaches, Psychological Intervention, Neuromuscular Control, Rehabilitation Exercise and Biomechanical Characteristics in Radiculomyelopathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- WHOQOL_BREF
研究概览
简要总结
Cervical radiculopathy and myelopathy are common degenerative disorders, which can create a large amount of social and medical burden. The aims of this study are(1) to investigate the functional outcomes progression before and after surgery, (2) to evaluate the biomechanical change and compensatory patterns of patients with or without decompression surgery, and (3) to design innovation intervention for the patients with cervical myelopathy and radiculopathy.
详细描述
Neck pain, which is common in population recently, is causing the huge burden in the global medical service system. Cervical myelopathy, that is induced by disc degeneration, is turning to be an alarming public health issue. The clinical manifestations of cervical myelopathy include neck/shoulder pain, numbness/weakness of four limbs, sensorimotor impairment, and sociopsychological dysfunction. However, most of the previous studies tend to justify patients, prognosis in a single dimension. The investigators realized that no standard protocol for management in patients with the variety of manifestation and severity of signs and symptoms.This study is purposed to integrate and analyze the finding in surgery selection, clinical manifestation, psychological consultation, compensatory patterns in the neuromusculoskeletal system, postural control, home exercise and biomechanical features. Then, the investigators will develop a complementary model in assessment and prediction of prognosis, and also an applicable standard guideline in the clinical setting. To achieve the expected target, the principal investigator will play the role as the main coordinator in the team. The 3-year plan is listed as below:
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In the first year, the patients will be recruited for projects from different co-investigators. The recruited participants will be allocated to different study group after assessment to ensure the most suitable intervention are offered to the participants.
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In the second year, the participants' recruitment will be continuing. The effectiveness previous treatment will be assessed. The study procedure will be adjusted based on pilot results.
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In the third year, the study finding of all co-investigators and results of the biomechanical analysis will be integrated to establish the model of prognosis prediction and clinical management guideline. This study will provide a complete clinical management guideline in cervical myelopathy, which is expected to be globally leading reference in the management of cervical myelopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as cervical myelopathy or radiculopathy based on imaging results
排除标准
- •With spondylolisthesis, rheumatoid arthritis, multiple sclerosis
- •With cancer/tumor
- •With neurological or psychological disorder
- •Not suitable for cervical decompression surgery or physical therapy
结局指标
主要结局
WHOQOL_BREF
时间窗: 1 year
Questionnaire
Kinematic variables
时间窗: 1 year
Range of motion
Modified Japanese Orthopaedic Association Scale (Modified JOA scale)
时间窗: 1 year
Investigator-administered scale Sub-scale 1: Motor Dysfunction score of the upper extremity (maximum score-5, minimum score-0) Sub-scale 2: Motor Dysfunction score of the lower extremity (maximum score-7, minimum score-0) Sub-scale 3: Sensory dysfunction score of the upper extremities (maximum score-3, minimum score-0) Sub-scale 4: Sphincter dysfunction (maximum score-3, minimum score-0) Higher score shows better outcome
Neuropathic Pain Symptom Inventory
时间窗: 1 year
Questionaire
Magnetic Resonance Imaging (MRI)
时间窗: 1 year
The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain
Grip and release test
时间窗: 1 year
Functional movement
Muscle activities in Electromyography (EMG)
时间窗: I year
Muscle activities in neck and lower limbs
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)
时间窗: 1 year
Questionnaire
5 times sit to stand
时间窗: 1 year
Functional movement
Kinetic variables
时间窗: 1 year
The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.
Neck Disability Index (NDI)
时间窗: 1 year
Questionnaire
Nurick scale
时间窗: 1 year
Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome
Foot taping test
时间窗: 1 year
Functional movement
10 second step test
时间窗: 1 year
Functional movement
SF-36
时间窗: 1 year
Questionnaire
次要结局
未报告次要终点
