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
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
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
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
