Investigation in Integrated Perspective of Radiculomyelopathy Patients

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396055
• Other study ID #: 201505093RINA
• Status: Completed
• Phase: N/A
• Start date: August 13, 2015
• Est. completion date: September 13, 2018

Study information

• Verified date: April 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: September 13, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Myelopathy
• Cervical Radiculopathy
• Radiculopathy
• Spinal Cord Diseases

Intervention

Other:
• specific rehabilitation exercise
specific rehabilitation exercise for patients with cervical myelopathy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index (NDI)	Questionnaire	1 year
Primary	Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)	Questionnaire	1 year
Primary	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	1 year
Primary	Nurick scale	Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome	1 year
Primary	Grip and release test	Functional movement	1 year
Primary	Foot taping test	Functional movement	1 year
Primary	5 times sit to stand	Functional movement	1 year
Primary	10 second step test	Functional movement	1 year
Primary	Kinetic variables	The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.	1 year
Primary	Neuropathic Pain Symptom Inventory	Questionaire	1 year
Primary	Magnetic Resonance Imaging (MRI)	The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain	1 year
Primary	SF-36	Questionnaire	1 year
Primary	WHOQOL_BREF	Questionnaire	1 year
Primary	Kinematic variables	Range of motion	1 year
Primary	Muscle activities in Electromyography (EMG)	Muscle activities in neck and lower limbs	I year