UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042321
Receipt number 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 2022/11/04 13:20:33

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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 or person

Institute

Kio University

Institute

Department

Personal name



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

Enrolling by invitation

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

2024 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

2022 Year 11 Month 04 Day



Link to view the page

Value
https://center6.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