NCT03396055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
Last Updated

February 18, 2021

Status Verified

April 1, 2020

Enrollment Period

3.1 years

First QC Date

December 26, 2017

Last Update Submit

February 17, 2021

Conditions

Cervical MyelopathyCervical Radiculopathy

Keywords

decompression surgeryfunctional outcomebiomechanicrehabilitation

Outcome Measures

Primary Outcomes (15)

  • 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Specific rehabilitation exercise

Other: specific rehabilitation exercise

Control

NO INTERVENTION

No intervention

Interventions

specific rehabilitation exerciseOTHER

specific rehabilitation exercise for patients with cervical myelopathy

Treatment group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as cervical myelopathy or radiculopathy based on imaging results

You may not qualify if:

  • With spondylolisthesis, rheumatoid arthritis, multiple sclerosis
  • With cancer/tumor
  • With neurological or psychological disorder
  • Not suitable for cervical decompression surgery or physical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 31345240DERIVED

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Dar-Ming Lai, Ph.D

    National Taiwan Unversity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 10, 2018

Study Start

August 13, 2015

Primary Completion

September 13, 2018

Study Completion

September 13, 2018

Last Updated

February 18, 2021

Record last verified: 2020-04

Locations

TW(1)