UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050041 |
|---|---|
| Receipt number | R000056421 |
| Scientific Title | Prospective Randomized Trial of the Efficacy for Intra-Articular Versus Extra-Articular steroid Injections in Knee Osteoarthritis |
| Date of disclosure of the study information | 2023/01/17 |
| Last modified on | 2023/01/25 09:53:45 |
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Basic information
Public title
Prospective Randomized Trial of the Efficacy for Intra-Articular Versus Extra-Articular steroid Injections in Knee Osteoarthritis
Acronym
SI study for knee OA
Scientific Title
Prospective Randomized Trial of the Efficacy for Intra-Articular Versus Extra-Articular steroid Injections in Knee Osteoarthritis
Scientific Title:Acronym
SI study for knee OA
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy for Intra-Articular Versus Extra-Articular steroid Injections in Knee Osteoarthritis and reveal the localization of the pain of knee osteoarthritis
Basic objectives2
Others
Basic objectives -Others
To investigate the association between MRI or plain radiography and the effect by the injection of steroid and do the sub group comparison
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of KOOS and NRS after the injection of steroid during 12 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intraarticular steroid injection
Interventions/Control_2
Extraarticular steroid injection
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age over 40 years old
2. Person who has been diagnosed as knee osteoarthritis regarding ACR criteria.
3. Person who has been informed and became consent with the study
Key exclusion criteria
1 Rheumatoid arthritis, multiple arthritis, and other autoimmune disease
2 History of total knee arthroplasty, high tibial osteotomy, and other knee surgery
3 History of intra-articular steroid injection in 6 months
4 In use of opioid analgesics
5 A plan for change of residence or long absence
6 Having difficulty talking Japanese
7 Having difficulty answering to questionnaires for cognitive decline
8 Inappropriate for injection
9 History of hypersensitivity for steroids
10 Person whom principal Investigator or co-Investigator judge to be inappropriate
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Nippon Medical School
Division name
Department of Orthopaedic Surgery
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL
03-3822-2131
watanabehiroshi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Nippon Medical School Musashi-Kosugi Hospital
Division name
Department of Orthopaedic Surgery
Zip code
211-8533
Address
1-383 Kosugi-machi, Nakahara-ku, Kawasaki, Kanagawa
TEL
044-733-5181
Homepage URL
watanabehiroshi@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
HIROSHI WATANABE
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toho Kamagaya Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chuorinri group
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
chuorinri.group@nms.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
| 2023 | Year | 01 | Month | 17 | 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
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056421
