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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042321
Receipt No. R000048310
Scientific Title Development and confirmation of reliability and validity of a Japanese version of the Constant Shoulder Score
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/25

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Basic information
Public title Development and confirmation of reliability and validity of a Japanese version of the Constant Shoulder Score
Acronym Development of a Japanese version of the Constant Shoulder Score
Scientific Title Development and confirmation of reliability and validity of a Japanese version of the Constant Shoulder Score
Scientific Title:Acronym Development of a Japanese version of the Constant Shoulder Score
Region
Japan

Condition
Condition Shoulder joint diseases
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to develop a Japanese version of the Constant Shoulder Score and confirm its reliability and validity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Constant Shoulder Score
Key secondary outcomes Shoulder pain, Pain Self-Efficacy Questionnaire, Shoulder-36, Quick DASH, PHQ-9, Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale, Range of motion in shoulder (active, passive)

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 Patients with shoulder joint disease
Key exclusion criteria People with any other condition affecting upper limb function to a greater extent than their shoulder pain.
People with cognitive impairment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Uritani
Organization Kio University
Division name Faculty of Health Science
Zip code 6350832
Address 4-2-2 Umaminaka Koryo-cho Kitakatsuragi-gun Nara
TEL 0745541601
Email d.uritani@kio.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Uritani
Organization Kio University
Division name Faculty of Health Science
Zip code 6350832
Address 4-2-2 Umaminaka Koryo-cho Kitakatsuragi-gun Nara
TEL 0745541601
Homepage URL
Email d.uritani@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio 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 Kio University
Address 4-2-2 Umaminaka Koryo-cho Kitakatsuragi-gun Nara
Tel 0745541601
Email soumu@kio.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
2020 Year 12 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 01 Day
Date of IRB
2020 Year 11 Month 17 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study using questionnaires

Management information
Registered date
2020 Year 11 Month 02 Day
Last modified on
2020 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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