UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057635 |
|---|---|
| Receipt number | R000065852 |
| Scientific Title | Extracorporeal shock wave therapy and platelet-rich plasma for bone marrow lesions in knee osteoarthritis: non-randomized controlled trial |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/12/15 15:10:57 |
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Basic information
Public title
Extracorporeal shock wave therapy and platelet-rich plasma for bone marrow lesions in knee osteoarthritis
Acronym
Extracorporeal shock wave therapy and platelet-rich plasma for bone marrow lesions in knee osteoarthritis
Scientific Title
Extracorporeal shock wave therapy and platelet-rich plasma for bone marrow lesions in knee osteoarthritis: non-randomized controlled trial
Scientific Title:Acronym
ESWT-PRP trial for KOA-BML
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of combined extracorporeal shock wave and PRP therapy for bone marrow lesions associated with knee osteoarthritis on clinical symptoms, knee joint function and motor function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee flexion range of motion, knee extension range of motion, knee extension muscle strength, hip abduction muscle strength, timed up & go test. time: before intervention, 1 month, 3 months, 5 months
Key secondary outcomes
Patient-reported outcome measures: Visual analogue scale, Knee injury and osteoarthritis outcome score, Hospital Anxiety and Ultrasonographic assessment: Distance in suprapatellar sac,Medial meniscal extrusion, Muscle brightness of medial vastus medialis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Extracorporeal shock wave (2000 shots, 3 times a week), injection of multi-platelet plasma (once), physical therapy (once a week for 5 months)
Interventions/Control_2
Extracorporeal shock wave (2000 shots, 3 times a week), physical therapy (once a week for 5 months)
Interventions/Control_3
physical therapy (once a week for 5 months)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with osteoarthritis of the knee, with a Visual Analogue Scale evaluation of 30 mm or more at the medial knee joint and bone marrow lesions at the medial tibiofemoral joint on MRI.
Key exclusion criteria
Grade IV in the Kellgren-Lawrence classification, prior ESWT or PRP therapy, history of knee trauma or neurological disease, bilateral symptomatic knee osteoarthritis, bone marrow lesions with osteonecrosis on MRI findings, systemic diseases such as rheumatoid arthritis, autoimmune diseases, tumors, and contraindications to ESWT systemic diseases such as rheumatoid arthritis, autoimmune diseases, and tumors, as well as those with contraindications to extracorporeal shock wave therapy.
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive Medical Sciences Research Institute
Zip code
559-8611
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
TEL
0666166911
kudo@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | shun |
| Middle name | |
| Last name | okada |
Organization
Morinomiya University of Medical Sciences
Division name
research support center
Zip code
559-8611
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
TEL
0666166911
Homepage URL
kenkyu@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences
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
Morinomiya University of Medical Sciences
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
Tel
0666166911
kenkyu@morinomiya-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
| 2025 | Year | 04 | 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
| 2025 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065852
