UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044763 |
|---|---|
| Receipt number | R000051127 |
| Scientific Title | Electrophysiological study in cervical myelopathy for appropriate diagnosis and postoperative prediction. |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2026/01/07 19:49:29 |
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Basic information
Public title
Electrophysiological study in cervical myelopathy for appropriate diagnosis and postoperative prediction.
Acronym
Electrophysiological study in cervical myelopathy.
Scientific Title
Electrophysiological study in cervical myelopathy for appropriate diagnosis and postoperative prediction.
Scientific Title:Acronym
Electrophysiological study in cervical myelopathy.
Region
| Japan |
Condition
Condition
cervical spondylotic myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the results of preoperative electrophysiological study for cervical spondylotic myelopathy are involved in postoperative improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual analog scale of numbness in limbs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Electrophysiological study
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
preoperative cervical spondylotic myelopathy patients
Key exclusion criteria
cervical spondylotic radiculapathy patients
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Kawasaki |
Organization
Nara Medical University
Division name
Orthopaedic surgery
Zip code
634-0813
Address
840 Shijyocho, Kashihara, Nara
TEL
0744-22-3051
sachi-kawa@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Kawasaki |
Organization
Nara Medical University
Division name
Orthopaedic surgery
Zip code
634-0813
Address
840 Shijyocho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
sachi-kawa@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Orthopedic Surgery Research Grant Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijyocho, Kashihara, Nara
Tel
0744-22-3051
sachi-kawa@naramed-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
Median VAS for upper limb improved from 8.9 to 3.0 mm at 1 year, while median VAS for lower limb improved from 4.5 to 2.1 mm. Adjusted N20 latency and N20 amplitude showed significant interaction with postoperative time. Post-hoc analyses demonstrate that the association between adjusted N20 latency and VAS for upper limb numbness was not significant until 3 months postoperatively but became significant at 6 months and persisted through 1 year.
Results date posted
| 2026 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Individuals who were scheduled cervical laminoplasty for DCM were included. Patients who could not perform preoperative and postoperative SEP were excluded.
Participant flow
Longitudinal associations between changes in SEP parameters and postoperative VAS for upper and lower limb numbness were examined using linear mixed-effects models, with patient-specific random intercepts to account for repeated measurements. All models were adjusted for age and diabetes mellitus.
Adverse events
None
Outcome measures
VASs for upper and lower limb numbness were gained without assistance from a surgeon before and 2 weeks, 3, 6, 12 months postoperatively. SEP examinations were performed at the same time-point, and we measured adjusted latencies and amplitudes for N9, N13, and N20, as well as central sensory conduction time (CSCT=N20-N13 latency) was calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051127
