UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048915 |
|---|---|
| Receipt number | R000055729 |
| Scientific Title | Factors determining the short-term clinical outcomes of conservative treatment in patients with supraspinatus tear |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2022/09/12 16:54:40 |
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Basic information
Public title
Research for the pain in patients with rotator cuff tears
Acronym
Research for the pain in patients with rotator cuff tears
Scientific Title
Factors determining the short-term clinical outcomes of conservative treatment in patients with supraspinatus tear
Scientific Title:Acronym
Factors determining the clinical outcomes of conservative treatment in patients with rotator cuff tear
Region
| Japan |
Condition
Condition
rotator cuff tears
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the factors correlated with the clinical outcomes of conservative treatment in patients wit supraspinatus tear
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Western Ontario Rotator Cuff Index
Key secondary outcomes
range of motion; muscle strength; muscle thickness; acromio-humeral distance
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
non-operative treatment with physical therapy
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
| 39 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who could elevate their arm above 90 degrees
Key exclusion criteria
Patients with a history of shoulder surgery or presence of rheumatoid arthritis, cervical disease, and neurological disease
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Ueda |
Organization
Takarazuka University of Medical and Healthcare
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
666-0162
Address
1 Midorigaoka, Hanayashiki, Takarazuka city, Hyogo pref., Japan
TEL
0727368600
yasuyuki-ueda@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Ueda |
Organization
Secretariat
Division name
Financing facilities section
Zip code
666-0162
Address
1 Midorigaoka, Hanayashiki, Takarazuka city, Hyogo pref., Japan
TEL
0727368600
Homepage URL
yinoue@tumh.ac.jp
Sponsor or person
Institute
kyoto university
Institute
Department
Personal name
Funding Source
Organization
Kyoto university
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
Kyoto university Graduate school and faculty of medicine, ethic comittee
Address
54 Kawaramachi, Seigoin, Sakyou-ward, Kyoto city, Kyoto pref., Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2022 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
145
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
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2022 | 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=R000055729
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
