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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040048
Receipt No. R000045624
Scientific Title Effectiveness of ultrasound-guided fascia hydrorelease on metatarsalgia without sonographic evidence of inflammation in patients with rheumatoid arthritis.
Date of disclosure of the study information 2020/04/03
Last modified on 2020/04/03

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Basic information
Public title Effectiveness of ultrasound-guided fascia hydrorelease on metatarsalgia without sonographic evidence of inflammation in patients with rheumatoid arthritis.
Acronym Effectiveness of ultrasound-guided fascia hydrorelease on metatarsalgia without sonographic evidence of inflammation in patients with rheumatoid arthritis.
Scientific Title Effectiveness of ultrasound-guided fascia hydrorelease on metatarsalgia without sonographic evidence of inflammation in patients with rheumatoid arthritis.
Scientific Title:Acronym Effectiveness of ultrasound-guided fascia hydrorelease on metatarsalgia without sonographic evidence of inflammation in patients with rheumatoid arthritis.
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm effectiveness and safety of ultrasound-guided fascia hydrorelease on metatarsalgia without sonographic evidence of inflammation in patients with rheumatoid arthritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes difference of the tenderness measured by Numerical Rating Scale (NRS) before and right after the injection.
Key secondary outcomes difference of pain on walking measured by Numerical Rating Scale (NRS) before and right after the injection, one week after the injection..

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 ultrasound-guided fascia hydrorelease (injection of 2ml Normal saline on the dorsal side of MTP joint)
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with rheumatoid arthritis who fulfill ACR/EULAR 2020 classification criteria and have tenderness on at least one MTP joint, on which gray scale is less than grade 1 and power doppler scale is zero.
Key exclusion criteria Patients who received intraarticular steroid injection, or patients who have tenosynovitis, Morton neuroma, interpalangeal bursitis.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masei
Middle name
Last name Suda
Organization Suwa Central Hospital
Division name Rheumatology
Zip code 3918503
Address 4300, Tamagawa, Chino-shi, Nagano, Japan
TEL 0266-72-1000
Email msuda@luke.ac.jp

Public contact
Name of contact person
1st name Masei
Middle name
Last name Suda
Organization Suwa Central Hospital
Division name Rheumatology
Zip code 3918503
Address 4300, Tamagawa, Chino-shi, Nagano, Japan
TEL 0266-72-1000
Homepage URL
Email msuda@luke.ac.jp

Sponsor
Institute Suwa Central Hospital
Institute
Department

Funding Source
Organization Japanese Non-surgical Orthopedics Society
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Suwa Central Hospital IRB
Address 4300, Tamagawa, Chino-shi, Nagano, Japan
Tel 0266-72-1000
Email msuda@luke.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 04 Month 03 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 Open public recruiting
Date of protocol fixation
2019 Year 08 Month 25 Day
Date of IRB
2019 Year 09 Month 09 Day
Anticipated trial start date
2020 Year 04 Month 03 Day
Last follow-up date
2020 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 03 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045624

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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