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Recruitment status
Unique ID issued by UMIN UMIN000025551
Receipt No. R000028791
Scientific Title Evaluation of Hypoxia in patients with frozen shoulder and of its change after transcatheter arterial embolization
Date of disclosure of the study information 2017/01/06
Last modified on 2017/01/05

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Basic information
Public title Evaluation of Hypoxia in patients with frozen shoulder and of its change after transcatheter arterial embolization
Acronym Hypoxia in frozen shoulder before and after embolization
Scientific Title Evaluation of Hypoxia in patients with frozen shoulder and of its change after transcatheter arterial embolization
Scientific Title:Acronym Hypoxia in frozen shoulder before and after embolization
Region
Japan

Condition
Condition Idiopathic Adhesive capsulitis (frozen shoulder)
Classification by specialty
Orthopedics Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the degree of hypoxia in patients with adhesive capsulitis and to evaluate of its change after transcatheter arterial embolization
Basic objectives2 Others
Basic objectives -Others etiology
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SUV-max ratio of FMISO-PET examination between affected side and unaffected side in region of interest before treatment
Key secondary outcomes The change of SUV-max ratio of FMISO-PET examination after transcatheter arterial embolization
SUV-max ratio of FDG-PET examination in region of interest
The change of SUV-max ratio of FDG-PET after embolization
MRI imaging scoring before and after embolziation
Pain VAS score before and after treatment
The change of serum marker before and after treatment
Range of motion before and after treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Transcatheter arterial embolization
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients who were diagnosed as adhesive capsulitis
2.having moderate to severe pain (Numerical rating score:NRS=5 or more)
3.age 20<, 80>
4.Shoulder surgeon judged that transcatheter arterial micro-shunt embolization is applicable for.
5.Patients who maintain major organ (bone marrow, heart, liver, lung, kidney) function.
6.Patients without diabetes mellitus
7.Provided written informed consent to undergo the procedure.
Key exclusion criteria 1.Patients who have undergoing or previous pathology in opposite shoulder
2.Patients with rotator cuff full thickness tear detected by MRI
3.Pregnant female
4.Prior shoulder surgery
5.Mental illness
6.Rheumatoid arthritis or Neoplasm
7.Patients who has been diagnosed as diabetes mellitus
8.Patients who received intra-articular steroid injection or who received oral steroi during last one months.
9.Patients who was decided not to be appropriate for this trial by physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code
Address Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL 03-3673-1221
Email okuno@edogawa.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code
Address Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL 03-3673-1221
Homepage URL
Email okuno@edogawa.or.jp

Sponsor
Institute Edogawa Hospital
Institute
Department

Funding Source
Organization Department of orthopedic surgery, Edogawa Hospital
Department of Nuclear medicine, International Medical center, Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor 1.Department of Nuclear medicine, International Medical center, Saitama Medical University
2.Department of orthopedic syrgery, School of medicine, Toho University
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
2017 Year 01 Month 06 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
Date of protocol fixation
2016 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 06 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
2017 Year 01 Month 05 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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