UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040483
Receipt number R000046199
Scientific Title A survey on stiff shoulder in a hospital staffs
Date of disclosure of the study information 2020/05/24
Last modified on 2022/11/21 09:54:13

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Basic information

Public title

A survey on stiff shoulder in a hospital staffs

Acronym

A survey on stiff shoulder in a hospital staffs

Scientific Title

A survey on stiff shoulder in a hospital staffs

Scientific Title:Acronym

A survey on stiff shoulder in a hospital staffs

Region

Japan


Condition

Condition

stiff shoulder

Classification by specialty

Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the factors that affect stiff shoulder

Basic objectives2

Others

Basic objectives -Others

muscle stiffness

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Numerical rating scale on stiff shoulder

Key secondary outcomes

Muscle stiffness, elastography


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

75 years-old >

Gender

Male and Female

Key inclusion criteria

none

Key exclusion criteria

none

Target sample size

370


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Onda

Organization

Zenshukai Hospital

Division name

Orthopaedic surgery

Zip code

379-2115

Address

54-1 Utsuboi-machi Maebashi City, Gunma

TEL

027-261-5410

Email

onda@zenshukai.com


Public contact

Name of contact person

1st name Akira
Middle name
Last name Onda

Organization

Zenshukai Hospital

Division name

Orthopaedic surgery

Zip code

379-2115

Address

54-1 Utsuboi-machi Maebashi City, Gunma

TEL

027-261-5410

Homepage URL


Email

onda@zenshukai.com


Sponsor or person

Institute

Zenshukai Hosupital

Institute

Department

Personal name



Funding Source

Organization

none

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

Institutional review board of Zenshukai hospital

Address

54-1 Utsuboi-machi Maebashi City, Gunma

Tel

027-261-5410

Email

onda@zenshukai.com


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 05 Month 24 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

369

Results

Three-hundred-and-fifty-nine participants were enrolled. Nearly 75% of subjects had katakori of various degrees. The time spent on the computer during work, being female, and unsatisfactory sleep were potential risk factors for katakori. Comparison of the matched 13 pairs showed a significantly stiffer trapezius in subjects with severe katakori symptoms, but no apparent differences in limb/trunk muscle mass.

Results date posted

2021 Year 12 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Hospital staffs

Participant flow

Lifestyle, physical and mental status, and katakori existense were assessed on primary survey. On secondary survey, elastography in the trapezius, limb/trunk muscle mass were compared between severely symptomatic subjects and controls, using propensity score matching.

Adverse events

none

Outcome measures

Existence of katakori, lifelstyle, stiffness of trapezius and muscle volume in limb/trunk.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 01 Month 05 Day

Date of IRB

2020 Year 02 Month 09 Day

Anticipated trial start date

2020 Year 05 Month 25 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 09 Month 30 Day


Other

Other related information

Existence or nonexistence of stiff shoulder, extent of stiff shoulder, lifestyle,echo analyses (elastography), and muscle volume


Management information

Registered date

2020 Year 05 Month 21 Day

Last modified on

2022 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046199


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name