Clinical trial NCT03396055: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Myelopathy
Cervical Radiculopathy
Keywords: decompression surgery
functional outcome
biomechanic
rehabilitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 452
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 1 year
measure: Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)
timeFrame: 1 year
measure: Modified Japanese Orthopaedic Association Scale (Modified JOA scale)
timeFrame: 1 year
measure: Nurick scale
timeFrame: 1 year
measure: Grip and release test
timeFrame: 1 year
measure: Foot taping test
timeFrame: 1 year
measure: 5 times sit to stand
timeFrame: 1 year
measure: 10 second step test
timeFrame: 1 year
measure: Kinetic variables
timeFrame: 1 year
measure: Neuropathic Pain Symptom Inventory
timeFrame: 1 year
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 1 year
measure: SF-36
timeFrame: 1 year
measure: WHOQOL_BREF
timeFrame: 1 year
measure: Kinematic variables
timeFrame: 1 year
measure: Muscle activities in Electromyography (EMG)
timeFrame: I year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan Unversity Hospital
name: Dar-Ming Lai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.