UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054312 |
|---|---|
| Receipt number | R000060066 |
| Scientific Title | Effect of Cerval Flexion on Spinal Cord Displacement-Investigation using MRI- |
| Date of disclosure of the study information | 2024/05/02 |
| Last modified on | 2025/05/05 07:35:01 |
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Basic information
Public title
Effect of Cerval Flexion on Spinal Cord Displacement-Investigation using MRI-
Acronym
Effect of Cerval Flexion on Spinal Cord Displacement-Investigation using MRI-
Scientific Title
Effect of Cerval Flexion on Spinal Cord Displacement-Investigation using MRI-
Scientific Title:Acronym
Effect of Cerval Flexion on Spinal Cord Displacement-Investigation using MRI-
Region
| Japan |
Condition
Condition
Lumbar canal stenosis, Lumbar disc herniation
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the amount of displacement of the spinal cord during cervical flexion after cervical spine flexion exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in spinal conus in cervical nuetral position and 60 degrees flexion before and after cevical flexion exercise
Key secondary outcomes
Amount of change in straight leg raising test
Amount of change in knee joint flexion isometric muscle strength
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform three sets of 20 passive cervical flexion movements in the supine
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy adults aged 20-29 who agreed to participate in this study
Key exclusion criteria
Who have low back, back, or neck pain
Who have positive neurological findings
Who have limitation of cervical range of motion
Who have diagnosed neck or thoracolumbar disease
Who have previous neck or thoracolumbar surgery
Who have claustrophobia
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Nihei |
Organization
Funabashi Orthopedic Hospital
Division name
Hospital Physical Therapy Department
Zip code
274-0822
Address
1-833 Hasamacho, Funabasi City, Chiba Prefecture
TEL
047-425-5585
ynihei@fff.or.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| Middle name | |
| Last name | Nihei |
Organization
Funabashi Orthopedic Hospital
Division name
Hospital Physical Therapy Department
Zip code
274-0822
Address
1-833 Hasamacho, Funabasi City, Chiba Prefecture
TEL
047-425-5585
Homepage URL
ynihei@fff.or.jp
Sponsor or person
Institute
Funabashi Orthopedic Hospital
Institute
Department
Personal name
Funding Source
Organization
Funabashi Orthopedic Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Funabashi Orthopedic Hospital
Address
1-833 Hasamacho, Funabasi City, Chiba Prefecture
Tel
047-425-5585
ynihei@fff.or.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
| 2024 | Year | 05 | Month | 02 | 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
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 02 | Day |
Last modified on
| 2025 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060066
