Investigation in Integrated Perspective of Radiculomyelopathy Patients
Primary Purpose
Cervical Myelopathy, Cervical Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
specific rehabilitation exercise
Sponsored by
About this trial
This is an interventional other trial for Cervical Myelopathy focused on measuring decompression surgery, functional outcome, biomechanic, rehabilitation
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control
Arm Description
Specific rehabilitation exercise
No intervention
Outcomes
Primary Outcome Measures
Neck Disability Index (NDI)
Questionnaire
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)
Questionnaire
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
Nurick scale
Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome
Grip and release test
Functional movement
Foot taping test
Functional movement
5 times sit to stand
Functional movement
10 second step test
Functional movement
Kinetic variables
The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.
Neuropathic Pain Symptom Inventory
Questionaire
Magnetic Resonance Imaging (MRI)
The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain
SF-36
Questionnaire
WHOQOL_BREF
Questionnaire
Kinematic variables
Range of motion
Muscle activities in Electromyography (EMG)
Muscle activities in neck and lower limbs
Secondary Outcome Measures
Full Information
NCT ID
NCT03396055
First Posted
December 26, 2017
Last Updated
February 17, 2021
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03396055
Brief Title
Investigation in Integrated Perspective of Radiculomyelopathy Patients
Official Title
Investigation of the Relationship Between Surgical Approaches, Psychological Intervention, Neuromuscular Control, Rehabilitation Exercise and Biomechanical Characteristics in Radiculomyelopathy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2015 (Actual)
Primary Completion Date
September 13, 2018 (Actual)
Study Completion Date
September 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Myelopathy, Cervical Radiculopathy
Keywords
decompression surgery, functional outcome, biomechanic, rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Specific rehabilitation exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
specific rehabilitation exercise
Intervention Description
specific rehabilitation exercise for patients with cervical myelopathy
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
Questionnaire
Time Frame
1 year
Title
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)
Description
Questionnaire
Time Frame
1 year
Title
Modified Japanese Orthopaedic Association Scale (Modified JOA scale)
Description
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
Time Frame
1 year
Title
Nurick scale
Description
Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome
Time Frame
1 year
Title
Grip and release test
Description
Functional movement
Time Frame
1 year
Title
Foot taping test
Description
Functional movement
Time Frame
1 year
Title
5 times sit to stand
Description
Functional movement
Time Frame
1 year
Title
10 second step test
Description
Functional movement
Time Frame
1 year
Title
Kinetic variables
Description
The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.
Time Frame
1 year
Title
Neuropathic Pain Symptom Inventory
Description
Questionaire
Time Frame
1 year
Title
Magnetic Resonance Imaging (MRI)
Description
The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain
Time Frame
1 year
Title
SF-36
Description
Questionnaire
Time Frame
1 year
Title
WHOQOL_BREF
Description
Questionnaire
Time Frame
1 year
Title
Kinematic variables
Description
Range of motion
Time Frame
1 year
Title
Muscle activities in Electromyography (EMG)
Description
Muscle activities in neck and lower limbs
Time Frame
I year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dar-Ming Lai, Ph.D
Organizational Affiliation
National Taiwan Unversity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31345240
Citation
Lin IS, Lai DM, Ding JJ, Chien A, Cheng CH, Wang SF, Wang JL, Kuo CL, Hsu WL. Reweighting of the sensory inputs for postural control in patients with cervical spondylotic myelopathy after surgery. J Neuroeng Rehabil. 2019 Jul 25;16(1):96. doi: 10.1186/s12984-019-0564-2.
Results Reference
derived
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Investigation in Integrated Perspective of Radiculomyelopathy Patients
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