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NCT Number: NCT03396055

Investigation in Integrated Perspective of Radiculomyelopathy Patients

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.

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Key information

Conditions

Cervical Myelopathy Cervical Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

specific rehabilitation exercise

Other

specific rehabilitation exercise for patients with cervical myelopathy

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2018
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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