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Investigation in Integrated Perspective of Radiculomyelopathy Patients

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ClinicalTrials.gov Identifier: NCT03396055
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Myelopathy Cervical Radiculopathy Other: specific rehabilitation exercise Not Applicable

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:

  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.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation of the Relationship Between Surgical Approaches, Psychological Intervention, Neuromuscular Control, Rehabilitation Exercise and Biomechanical Characteristics in Radiculomyelopathy Patients
Actual Study Start Date : August 13, 2015
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Specific rehabilitation exercise
Other: specific rehabilitation exercise
specific rehabilitation exercise for patients with cervical myelopathy

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. Neck Disability Index (NDI) [ Time Frame: 1 year ]
    Questionnaire

  2. Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ) [ Time Frame: 1 year ]
    Questionnaire

  3. Modified Japanese Orthopaedic Association Scale (Modified JOA scale) [ Time Frame: 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

  4. Nurick scale [ Time Frame: 1 year ]
    Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome

  5. Grip and release test [ Time Frame: 1 year ]
    Functional movement

  6. Foot taping test [ Time Frame: 1 year ]
    Functional movement

  7. 5 times sit to stand [ Time Frame: 1 year ]
    Functional movement

  8. 10 second step test [ Time Frame: 1 year ]
    Functional movement

  9. Kinetic variables [ Time Frame: 1 year ]
    The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.

  10. Neuropathic Pain Symptom Inventory [ Time Frame: 1 year ]
    Questionaire

  11. Magnetic Resonance Imaging (MRI) [ Time Frame: 1 year ]
    The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain

  12. SF-36 [ Time Frame: 1 year ]
    Questionnaire

  13. WHOQOL_BREF [ Time Frame: 1 year ]
    Questionnaire

  14. Kinematic variables [ Time Frame: 1 year ]
    Range of motion

  15. Muscle activities in Electromyography (EMG) [ Time Frame: I year ]
    Muscle activities in neck and lower limbs



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396055


Contacts
Contact: motor dysfunction of lower extremities Hsu, Ph.D 886-2-3366-8127 wlhsu@ntu.edu.tw
Contact: Dar-Ming Lai, Ph.D dmlai@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Dar-Ming Lai, Ph.D       dmlai@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Dar-Ming Lai, Ph.D National Taiwan Unversity Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03396055     History of Changes
Other Study ID Numbers: 201505093RINA
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
decompression surgery
functional outcome
biomechanic
rehabilitation

Additional relevant MeSH terms:
Radiculopathy
Spinal Cord Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases