UMIN-CTR Clinical Trial

Basic information
Public title	A diagnostic method of musculoskeletal pain using the PET-MRI.
Acronym	PET-MRI diagnosis of musculoskeletal pain.
Scientific Title	A diagnostic method of musculoskeletal pain using the PET-MRI.
Scientific Title:Acronym	PET-MRI diagnosis of musculoskeletal pain.
Region	Japan

Condition
Condition	shoulder joint problems lumbar pain
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	research of correlation of morphological changes and inflammation
Basic objectives2	Others
Basic objectives -Others	pathological research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relation of locations between morphological diagnosis through MRI and FDG accumulation in PET
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	administration of FDG and taking lumbar MRI for the patients of shoulder joint pain
Interventions/Control_2	administration of FDG and taking shoulder MRI for the lumbago patients
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The orthopaedic outpatients of Kyoto University Hospital aged not less than 20 years old, who are suffered from shoulder or lumbar pain, who are thought to need taking MRI for diagnosis, and who can independently express their participation in this study.
Key exclusion criteria	1) the patients who express both of shoulder and lumbar pain. 2) the patients who had surgeries in the shoulder or lumbar spine. 3) the patients who have intracephalic aneurysm clips or heart pacemakers which are contraindicated to MRI. 4) the patients whom the examiners do not think applicable. 5) the patients who show more than 200 mg/dl of blood glucose level during the examination.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Ryuzo Middle name Last name Arai
Organization	Kyoto University
Division name	Department of Orthopaedic Surgery
Zip code	606-8507
Address	54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto city
TEL	075-366-7734
Email	rarai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name N/A Middle name Last name N/A
Organization	Kyoto University Hospital
Division name	Consultation support center
Zip code	606-8507
Address	54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto city
TEL	075-751-4748
Homepage URL
Email	ctsodan@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	2020 Year 06 Month 22 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	2020 Year 06 Month 12 Day
Date of IRB	2020 Year 06 Month 12 Day
Anticipated trial start date	2020 Year 06 Month 12 Day
Last follow-up date	2021 Year 04 Month 13 Day
Date of closure to data entry	2021 Year 04 Month 13 Day
Date trial data considered complete	2021 Year 04 Month 13 Day
Date analysis concluded	2021 Year 04 Month 13 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 15 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045451