Cervical MyelopathyNCT03396055
Investigation in Integrated Perspective of Radiculomyelopathy Patients
A study testing specific rehabilitation exercise in people with Cervical Myelopathy and Cervical Radiculopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Myelopathy, Cervical Radiculopathy
- What is being tested?
- specific rehabilitation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Aug 2015to 13 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed as cervical myelopathy or radiculopathy based on imaging results
Who cannot join
- With spondylolisthesis, rheumatoid arthritis, multiple sclerosis
- With cancer/tumor
- With neurological or psychological disorder
- Not suitable for cervical decompression surgery or physical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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
- Being tested
- specific rehabilitation exercise
- Keywords
- decompression surgery, functional outcome, biomechanic, rehabilitation
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific rehabilitation exerciseOther
specific rehabilitation exercise for patients with cervical myelopathy
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Specific rehabilitation exercise Receives: Other: specific rehabilitation exercise |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
Questionnaire
Measured: 1 year
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)
Questionnaire
Measured: 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
Measured: 1 year
Nurick scale
Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome
Measured: 1 year
Grip and release test
Functional movement
Measured: 1 year
Foot taping test
Functional movement
Measured: 1 year
5 times sit to stand
Functional movement
Measured: 1 year
10 second step test
Functional movement
Measured: 1 year
Kinetic variables
The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.
Measured: 1 year
Neuropathic Pain Symptom Inventory
Questionaire
Measured: 1 year
Magnetic Resonance Imaging (MRI)
The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain
Measured: 1 year
SF-36
Questionnaire
Measured: 1 year
WHOQOL_BREF
Questionnaire
Measured: 1 year
Kinematic variables
Range of motion
Measured: 1 year
Muscle activities in Electromyography (EMG)
Muscle activities in neck and lower limbs
Measured: I year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start13 Aug 2015
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dar-Ming Lai, Ph.D, Principal investigator, National Taiwan Unversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396055
- Sponsor's protocol ID
- 201505093RINA
- Status last verified
- Apr 2020
- First submitted
- 26 Dec 2017
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31345240
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Surgical Approaches, Psychological Intervention, Neuromuscular Control, Rehabilitation Exercise and Biomechanical Characteristics in Radiculomyelopathy Patients
- ClinicalTrials.gov ID
- NCT03396055
- Acronym / sponsor ID
- 201505093RINA
- Conditions
- Cervical Myelopathy, Cervical Radiculopathy
- Keywords
- decompression surgery, functional outcome, biomechanic, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: specific rehabilitation exerciseSpecific rehabilitation exercise |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed as cervical myelopathy or radiculopathy based on imaging results
Key exclusion criteria (4 listed)
- With spondylolisthesis, rheumatoid arthritis, multiple sclerosis
- With cancer/tumor
- With neurological or psychological disorder
- Not suitable for cervical decompression surgery or physical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specific rehabilitation exercisespecific rehabilitation exercise for patients with cervical myelopathy | Other | Treatment group |
Primary outcome
Neck Disability Index (NDI)
Time frame: 1 year
Questionnaire
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire (JOACMEQ)
Time frame: 1 year
Questionnaire
Modified Japanese Orthopaedic Association Scale (Modified JOA scale)
Time frame: 1 year
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
Nurick scale
Time frame: 1 year
Investigator-administered scale The total maximum score is 5: the total minimum score is 0. Higher score shows worse outcome
Grip and release test
Time frame: 1 year
Functional movement
Foot taping test
Time frame: 1 year
Functional movement
5 times sit to stand
Time frame: 1 year
Functional movement
10 second step test
Time frame: 1 year
Functional movement
Kinetic variables
Time frame: 1 year
The ground reaction force, moment and center of pressure recorded by force platform during standing and ambulation.
Neuropathic Pain Symptom Inventory
Time frame: 1 year
Questionaire
Magnetic Resonance Imaging (MRI)
Time frame: 1 year
The cortical network of patients assessed by Diffusion Spectrum Imaging of the brain
SF-36
Time frame: 1 year
Questionnaire
WHOQOL_BREF
Time frame: 1 year
Questionnaire
Kinematic variables
Time frame: 1 year
Range of motion
Muscle activities in Electromyography (EMG)
Time frame: I year
Muscle activities in neck and lower limbs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 31345240Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dar-Ming Lai, Ph.D principal investigator
National Taiwan Unversity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific rehabilitation exercise in people with Cervical Myelopathy and Cervical Radiculopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI) (time frame: 1 year). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.