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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Radiculopathy; Cervical Myelopathy
• Intervention / Treatment: Other: specific rehabilitation exercise

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
• Enrollment (Actual): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No intervention
EXPERIMENTAL: Treatment group; Specific rehabilitation exercise	Other: specific rehabilitation exercise; specific rehabilitation exercise for patients with cervical myelopathy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Dar-Ming Lai, Ph.D, National Taiwan Unversity Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2015
• Primary Completion (ACTUAL): September 13, 2018
• Study Completion (ACTUAL): September 13, 2018

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; functional outcome; biomechanic; decompression surgery
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Spinal Cord Diseases
• Other Study ID Numbers: 201505093RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No