UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053296 |
|---|---|
| Receipt number | R000060830 |
| Scientific Title | Factors determining the short-term clinical outcomes of conservative treatment in patients with supraspinatus tear |
| Date of disclosure of the study information | 2024/01/09 |
| Last modified on | 2024/01/09 13:35:23 |
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Basic information
Public title
Factors determining the short-term clinical outcomes of conservative treatment in patients with supraspinatus tear
Acronym
Factors determining the short-term clinical outcomes of conservative treatment in patients with supraspinatus tear
Scientific Title
Factors determining the short-term clinical outcomes of conservative treatment in patients with supraspinatus tear
Scientific Title:Acronym
Factors determining the short-term clinical outcomes of conservative treatment in patients with supraspinatus tear
Region
| Japan |
Condition
Condition
supraspinatus tear
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to identify the factors that correlated with the better and worse clinical outcomes in symptomatic patients with RCT using multiple regression analysis of changes in physical parameters and medical information before and after conservative treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Western Ontario Rotator Cuff index
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
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
| 20 | years-old | < |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
SSP tear is diagnosed using magnetic resonance imaging or arthrography examination using fluoroscopy, and patients who could elevate their arms 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
30
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 Scienc
Zip code
666-0162
Address
1 Midorigaoka, Hanayashiki, Takarazuka city, Hyogo pref., Japan
TEL
+81-72-736-8642
yasuyuki-ueda@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Youko |
| Middle name | |
| Last name | Inoue |
Organization
Takarazuka University of Medical and Healthcare
Division name
General affairs
Zip code
666-0162
Address
1 Midorigaoka, Hanayashiki, Takarazuka city, Hyogo pref., Japan
TEL
+81-72-736-8642
Homepage URL
yinoue@tumh.ac.jp
Sponsor or person
Institute
Takarazuka University of Medical and Healthcare
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kyoto University Graduate School of Medicine
Address
54 Shogoin Kawaracho, Sakyo Ward, Kyoto
Tel
+81-75-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
CRB5180002
Org. issuing International ID_1
Japan registry of clinical trials
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 | 01 | Month | 09 | Day |
Related information
URL releasing protocol
https://docs.google.com/document/d/1_SIpXRS7odqR6yFblVVXN3hdXIyUgM2jLl3xDnnnYfw/edit?usp=sharing
Publication of results
Unpublished
Result
URL related to results and publications
https://docs.google.com/document/d/1zpXc5wgFZvtIj49qj8w6y_H0gqITinBotovidJJuKQ0/edit?usp=sharing
Number of participants that the trial has enrolled
30
Results
The average Western Ontario rotator cuff index score improved from 1067 pre-treatment to 997 post-treatment, but without a significant difference (p = 0.29). The multiple regression analysis revealed that supraspinatus tendon thickness and muscle strength in shoulder external rotation at 90 degrees scaption had a significant effect on the change in the Western Ontario rotator cuff index score. (R2 = 0.44, p < 0.01).
Results date posted
| 2024 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who was diagnosed supraspinatus tear, and undergone the conservative treatment
Participant flow
Recruitment would be conducted for cases diagnosed with supraspinatus tendon rupture at Nobuhara Hospital after explaining the purpose of the research and obtaining consent
Adverse events
No
Outcome measures
Western Ontario Rotator Cuff Index, Range of motion, muscle strength, tendon thickness of supaspinatus, muscle thickness of rotator cuff
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 18 | 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
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060830
