Investigation in Integrated Perspective of Radiculomyelopathy Patients

NCT ID: NCT03396055

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-13
• Study Completion Date: 2018-09-13

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.

Conditions

Cervical Myelopathy; Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment group

Specific rehabilitation exercise

Group Type: EXPERIMENTAL

specific rehabilitation exercise

Intervention Type: OTHER

specific rehabilitation exercise for patients with cervical myelopathy

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

specific rehabilitation exercise

specific rehabilitation exercise for patients with cervical myelopathy

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dar-Ming Lai, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Unversity Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 31345240 (View on PubMed)

Other Identifiers

201505093RINA

Identifier Type: -

Identifier Source: org_study_id