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Investigation in Integrated Perspective of Radiculomyelopathy Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03396055
Enrollment
452
Registered
2018-01-10
Start date
2015-08-13
Completion date
2018-09-13
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Myelopathy, Cervical Radiculopathy

Keywords

decompression surgery, functional outcome, biomechanic, rehabilitation

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: 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.

Interventions

OTHERspecific rehabilitation exercise

specific rehabilitation exercise for patients with cervical myelopathy

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neck Disability Index (NDI)1 yearQuestionnaire
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)1 yearQuestionnaire
Modified Japanese Orthopaedic Association Scale (Modified JOA scale)1 yearInvestigator-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 scale1 yearInvestigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome
Grip and release test1 yearFunctional movement
Foot taping test1 yearFunctional movement
5 times sit to stand1 yearFunctional movement
10 second step test1 yearFunctional movement
Kinetic variables1 yearThe ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.
Neuropathic Pain Symptom Inventory1 yearQuestionaire
Magnetic Resonance Imaging (MRI)1 yearThe cortical network of patients assessed by Diffusion Spectrum Imaging of the brain
SF-361 yearQuestionnaire
WHOQOL_BREF1 yearQuestionnaire
Kinematic variables1 yearRange of motion
Muscle activities in Electromyography (EMG)I yearMuscle activities in neck and lower limbs

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026