UMIN-CTR Clinical Trial

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
Email	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
Email	yinoue@tumh.ac.jp

Sponsor
Institute	kyoto university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055729