UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032195 |
|---|---|
| Receipt number | R000036645 |
| Scientific Title | Comprehensive investigation of pathology in non-specific neck pain by non-invasive evaluation |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2023/10/23 15:23:33 |
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Basic information
Public title
Comprehensive investigation of pathology in non-specific neck pain by non-invasive evaluation
Acronym
Investigation of pathology in non-specific neck pain
Scientific Title
Comprehensive investigation of pathology in non-specific neck pain by non-invasive evaluation
Scientific Title:Acronym
Investigation of pathology in non-specific neck pain
Region
| Japan |
Condition
Condition
non-specific neck pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comprehensive investigation of pathology in non-specific neck pain by non-invasive evaluation
Basic objectives2
Others
Basic objectives -Others
Investigation of pathology in non-specific neck pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between subjects who have non-specific neck pain and healthy volunteers in mental test, functional disturbance, muscle stiffness, fatty infiltration in muscles, and brain activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions as a physical examinations:
Ultrasonic device
Spinal Mouse
MRI
Interventions/Control_2
Interventions as a physical examinations:
Ultrasonic device
Spinal Mouse
MRI
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
1) Possible to obtain an informed consent
2) Currently, medical treatment is not received for serious health reasons such as mental / neurological diseases.
3) 20 years old and over
4) subjects who have primary chronic neck pain or healthy subjects
5) Dominant arm is right
Key exclusion criteria
1) Patients who have secondary shoulder neck pain such as cervical spondylotic radiculopathy
2) A woman suspected of being pregnant.
3) Complete motor paralysis
4) Subjects who have contraindication conditions on MRI imaging.
5) Others are deemed inappropriate as subjects by doctor's judgment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Shitara |
Organization
Gunma University Hospital
Division name
Orthopedic Surgery
Zip code
3718511
Address
3-39-15, Showa, Maebashi, Gunma, Japan
TEL
027-220-8269
hshitara@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Shitara |
Organization
Gunma University Hospital
Division name
Orthopedic Surgery
Zip code
3718511
Address
3-39-15, Showa, Maebashi, Gunma, Japan
TEL
027-220-8269
Homepage URL
hshitara@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
MEXT/JSPS KAKENH
Grant-in-Aid for Research Activity Start-up
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research
Address
3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
群馬大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | 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
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036645
