UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052190 |
|---|---|
| Receipt number | R000059388 |
| Scientific Title | Elucidation of central motor control in rotator cuff tear of the shoulder |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2023/09/12 21:54:24 |
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Basic information
Public title
Elucidation of central motor control in rotator cuff tear of the shoulder
Acronym
Elucidation of central motor control in rotator cuff tear of the shoulder
Scientific Title
Elucidation of central motor control in rotator cuff tear of the shoulder
Scientific Title:Acronym
Elucidation of central motor control in rotator cuff tear of the shoulder
Region
| Japan |
Condition
Condition
rotator cuff tear of the shoulder
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify peripharal and central motor contoral in rotator cuff tear of the shoulder
Basic objectives2
Others
Basic objectives -Others
To clarify peripharal and central motor contoral in rotator cuff tear of the shoulder
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fMRI,fNIRS:Differences in brain activity between patients with rotator cuff tear and healthy subjects
APAs:Differences in muscle activity and parameters acquired by center of pressure (COP) measurements of the patient group compared to healthy subjects
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
<Patient>
1) 20 years of age or older
2) Diagnosed with a right shoulder rotator cuff tear (excluding a single tear of the subscapularis tendon) with a small or middle size of tear according to the Cofield classification
3) Right-handed
4) Patients scheduled to undergo arthroscopic rotator cuff repair
5) Have written consent to participate in this study.
<healthy subjects>
1) 20 years of age or older
2) Right-handed
3) No shoulder rotator cuff tear
4) No complaints of shoulder pain
5) No painful disease
6) Who can obtain written consent to participate in this study
Key exclusion criteria
<patients>
(1) Patients with contraindications to MRI
(2) Patients who are judged by the physician to be inappropriate for the study.
(3) Patients who are unable to assume the study position (shoulder flexion and abduction)
4) Patients with psychoneurotic disorders who are not receiving medical treatment
5) Patients who are unable to discontinue medications that may affect the central nervous system (tramadol, pregabalin, myrogabalin, duloxetine, and other antipsychotic drugs)
6) Patients whose pain is induced by a weight of 1% of body weight in Study 1.
<healthy subjects>
1) Subjects with contraindications to MRI
2) Other subjects who are judged by the physician to be inappropriate for inclusion in the study.
3) Patients with psychoneurotic disorders who are not receiving medical treatment.
4) Patients taking medications that may affect the central nervous system (tramadol, pregabalin, myrogabalin, duloxetine, other antipsychotic drugs)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Shitara |
Organization
Department of Orthopaedic Surgery,
Gunma University Graduate School of Medicine
Division name
Orthpedic
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
0272207111
hshitara@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Fukuhisa |
| Middle name | |
| Last name | Ino |
Organization
Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
Division name
Orthpedic
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
0272207111
Homepage URL
inofuku423@gmail.com
Sponsor or person
Institute
Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
3-39-15 Showa-machi, Maebashi, Gunma
none
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
| 2023 | Year | 09 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sixty patients who meet the selection criteria will be recruited from the College, and 20 healthy patients who meet the selection criteria will be recruited from other hospital-affiliated gyms.
Management information
Registered date
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059388
