Investigation in Integrated Perspective of Radiculomyelopathy Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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. 2. 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.

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

Conditions
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Cervical Myelopathy, Cervical Radiculopathy

Intervention / Treatment
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* Other: specific rehabilitation exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as cervical myelopathy or radiculopathy based on imaging results Exclusion Criteria: With spondylolisthesis, rheumatoid arthritis, multiple sclerosis With cancer/tumor With neurological or psychological disorder Not suitable for cervical decompression surgery or physical therapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Specific rehabilitation exercise | Other: specific rehabilitation exercise<br>* specific rehabilitation exercise for patients with cervical myelopathy<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | Questionnaire | 1 year | 
| Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ) | Questionnaire | 1 year | 
| Modified Japanese Orthopaedic Association Scale (Modified JOA scale) | 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 | 1 year | 
| Nurick scale | Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome | 1 year | 
| Grip and release test | Functional movement | 1 year | 
| Foot taping test | Functional movement | 1 year | 
| 5 times sit to stand | Functional movement | 1 year | 
| 10 second step test | Functional movement | 1 year | 
| Kinetic variables | The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation. | 1 year | 
| Neuropathic Pain Symptom Inventory | Questionaire | 1 year | 
| Magnetic Resonance Imaging (MRI) | The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain | 1 year | 
| SF-36 | Questionnaire | 1 year | 
| WHOQOL_BREF | Questionnaire | 1 year | 
| Kinematic variables | Range of motion | 1 year | 
| Muscle activities in Electromyography (EMG) | Muscle activities in neck and lower limbs | I year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decompression surgery, functional outcome, biomechanic, rehabilitation