UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040048 |
|---|---|
| Receipt number | 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 17:53:32 |
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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
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
msuda@luke.ac.jp
Sponsor or person
Institute
Suwa Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045624
