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临床试验/NCT03396055
NCT03396055已完成不适用

Investigation of the Relationship Between Surgical Approaches, Psychological Intervention, Neuromuscular Control, Rehabilitation Exercise and Biomechanical Characteristics in Radiculomyelopathy Patients

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2015年8月13日最近更新:
适应症

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:

  1. 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.

  2. 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.

  3. 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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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