UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042899 |
|---|---|
| Receipt number | R000048970 |
| Scientific Title | Surveillance of medical treatment of frozen shoulder in Japan |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2023/07/10 11:01:46 |
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Basic information
Public title
Surveillance of medical treatment of frozen shoulder in Japan
Acronym
Surveillance of frozen shoulder in Japan
Scientific Title
Surveillance of medical treatment of frozen shoulder in Japan
Scientific Title:Acronym
Surveillance of frozen shoulder
Region
| Japan |
Condition
Condition
frozen shoulder
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Anesthesiology |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey medical treatment of frozen shoulder and consider efficacy of each treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effective medical treatment, which is adapted at various hospital
Key secondary outcomes
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
frozen shoulder
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University
Division name
Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
Seiryo-cho 1-1, Aoba-ku, Sendai
TEL
0227177321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University
Division name
Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
Seiryo-cho 1-1, Aoba-ku, Sendai
TEL
0227177321
Homepage URL
yamauchi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Tohoku University Hospital
Address
Seiryo-cho 2-1, Aoba-ku, Sendai
Tel
022-728-4105
hosp-ken@grp.tohoku.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
| 2021 | Year | 01 | Month | 05 | 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
1030
Results
Rate of responder was 18.6% (1030/5527).
Major treatments were as below; at inflammation stage, NSAIDs and intraarthrer injection; at contracture stage, nerve block and rehabilitation; and at recovery stage, rehabilitation. Medication was taken at all stages.
Results date posted
| 2023 | Year | 07 | Month | 10 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
It is taking time to publish a journal in English.
Date of the first journal publication of results
| 2023 | Year | 10 | Month | 01 | Day |
Baseline Characteristics
Japan Shoulder Society and Japan Society of Pain Clinicians
Participant flow
none
Adverse events
none
Outcome measures
Surveyrance to medical doctors
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Oral presentation at The 33rd Annual Meeting of Japan Gediatric Anesthesia, 2021.2.20-21 in Fukuoka.
Management information
Registered date
| 2021 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048970
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
