UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017784
Receipt No. R000020600
Scientific Title The effect of hyaluronic acid injection for primary frozen shoulder
Date of disclosure of the study information 2015/07/01
Last modified on 2016/06/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of hyaluronic acid injection for primary frozen shoulder
Acronym Hyaluronic acid injection for primary frozen shoulder
Scientific Title The effect of hyaluronic acid injection for primary frozen shoulder
Scientific Title:Acronym Hyaluronic acid injection for primary frozen shoulder
Region
Japan

Condition
Condition primary frozen shoulder
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy for hyaluronic acid injection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual analog pain scale
Key secondary outcomes Constant score
Shoulder 36 score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hyaluronic acid injection to the shoulder joint
Interventions/Control_2 No treatment
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria primary frozen shoulder
Key exclusion criteria diabetes mellitus
hepatic disorder
pregnant woman
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Takagishi
Organization Gunma University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 3-39-22 Showa-Machi, Maebashi, Gunma
TEL 027-220-8269
Email ktakagishi@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Yamamoto
Organization Gunma University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 3-39-22 Showa-Machi, Maebashi, Gunma
TEL 027-220-8269
Homepage URL
Email a.yamamoto@gunma-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 07 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 Terminated
Date of protocol fixation
2015 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 02 Day
Last modified on
2016 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.