UMIN-CTR Clinical Trial

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

Idiopathic Adhesive capsulitis (frozen shoulder)

Classification by specialty

Orthopedics

Radiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Edogawa Hospital

Institute

Department

Personal name

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

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

01

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

01

Month

05

Day

Last modified on

2017

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028791