UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Hypoxia in patients with frozen shoulder and of its change after transcatheter arterial embolization
Title of the study (Brief title)	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	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention Center
Address	Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Email	okuno@edogawa.or.jp

Public contact
Name of contact person	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention Center
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 12 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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