UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of hyaluronic acid injection for primary frozen shoulder
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kenji Takagishi
Organization	Gunma University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	3-39-22 Showa-Machi, Maebashi, Gunma
TEL	027-220-8269
Email	ktakagishi@gunma-u.ac.jp

Public contact
Name of contact person	Atsushi Yamamoto
Organization	Gunma University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020600