UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056999 |
|---|---|
| Receipt number | R000065136 |
| Scientific Title | Extracorporeal shockwave therapy and regenerative medicine and their combination therapy for knee osteoarthritis |
| Date of disclosure of the study information | 2025/02/25 |
| Last modified on | 2025/02/11 18:56:15 |
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Basic information
Public title
Extracorporeal shockwave therapy and regenerative medicine and their combination therapy for knee osteoarthritis
Acronym
Extracorporeal shockwave therapy and regenerative medicine and their combination therapy for knee osteoarthritis
Scientific Title
Extracorporeal shockwave therapy and regenerative medicine and their combination therapy for knee osteoarthritis
Scientific Title:Acronym
Extracorporeal shockwave therapy and regenerative medicine and their combination therapy for knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the therapeutic efficacy of extracorporeal shock wave therapy (ESWT) for knee osteoarthritis, the therapeutic effect of regenerative medicine such as PRP therapy, APS therapy, and MSC therapy, and the therapeutic efficacy of ESWT and their combination therapy with regenerative medicine by retrospective survey based on patient data conducted at N Clinic.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
KOOS (Knee injury and Osteoarthritis Outcome Score) data before therapy and at 1 month, 3 months, and 6 months after therapy
Key secondary outcomes
MRI image data before therapy and at 1 month, 3 months, and 6 months after therapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with knee osteoarthritis by X-ray at N Clinic or another hospital, and received intra-articular injections of hyaluronic acid, but the pain did not improve
Key exclusion criteria
Patients who have already undergone surgery or other treatments for knee osteoarthritis and those therapeutic effects are likely to be involved, as well as patients with metabolic or infectious diseases such as RA, are excluded from the study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | KUMAI |
Organization
Waseda University
Division name
Faculty of Sports Sciences
Zip code
359-1192/3591192
Address
2-579-15 Mikajima, Tokorozawa City, Saitama, Japan
TEL
04-2947-6774
kumakumat@waseda.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | NAKASATO |
Organization
N clinic
Division name
medical office
Zip code
5960045/5960045
Address
3-10-10 Bessho-cho Kishiwada City, Osaka,Japan
TEL
0724324976
Homepage URL
https://www.n-cli.com
nakasato@n-cli.com
Sponsor or person
Institute
Waseda university
Institute
Department
Personal name
Tsukasa KUMAI
Funding Source
Organization
None
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
Office of Reseach Ethics Waseda University
Address
1-104 Totsukamachi, Sinjyuku-ku,Tokyo,Japan
Tel
03-5273-9807/+81-352739807
rps-management@list.waseda.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
| 2025 | Year | 02 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At N clinic, focused extracorporeal shockwave therapy (ESWT)has been performed on bone pain caused by BML, which is one of the causes of knee osteoarthritis pain, and has shown excellent effects, but the effect has been limited. In addition, intra-articular injections of platelet-rich plasma (PRP) therapy and autologous protein solution (APS) therapy have been performed for synovitis, which is the cause of pain in the joint cavity, but the effect of these therapy has also been limited. Therefore, a combination of APS therapy and ESWT therapy has been performed in patients with both synovitis and BML, and has shown even better effects. However ESWT alone and the combination of APS therapy and ESWT had a limited therapeutic effect.
It was found that there are so-called refractory BML with osteonecrosis and bone cysts and so-called refractory BML with rupture of the subchondral bone plate in cases where the treatment effect is not good. Therefore, for the purpose of improving the subchondral bone plate, MSC(mesenchymal stromal cell) was injected intraarticular and intraosseous, and ESWT was performed before and after the injection of MSC for patients with knee OA with refractory BML.
Management information
Registered date
| 2025 | Year | 02 | Month | 11 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065136
