UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057466 |
|---|---|
| Receipt number | R000065654 |
| Scientific Title | Verification of the therapeutic effect of a new physiotherapy device for synovitis associated with knee osteoarthritis:Comparison of Radial Pressure Wave(RPW)or repetitive Pulse Magnetic Stimulation(rPMS)and conventional Ultrasound therapy device(US) |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/31 18:21:11 |
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Basic information
Public title
Verification of the therapeutic effect of a new physiotherapy device for synovitis associated with knee osteoarthritis:Comparison of Radial Pressure Wave(RPW)or repetitive Pulse Magnetic Stimulation(rPMS)and conventional Ultrasound therapy device(US)
Acronym
Verification of the therapeutic effect of a new physiotherapy device for synovitis associated with knee osteoarthritis:Comparison of Radial Pressure Wave(RPW)or repetitive Pulse Magnetic Stimulation(rPMS)and conventional Ultrasound therapy device(US)
Scientific Title
Verification of the therapeutic effect of a new physiotherapy device for synovitis associated with knee osteoarthritis:Comparison of Radial Pressure Wave(RPW)or repetitive Pulse Magnetic Stimulation(rPMS)and conventional Ultrasound therapy device(US)
Scientific Title:Acronym
Verification of the therapeutic effect of a new physiotherapy device for synovitis associated with knee osteoarthritis:Comparison of Radial Pressure Wave(RPW)or repetitive Pulse Magnetic Stimulation(rPMS)and conventional Ultrasound therapy device(US)
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This purpose is to verify the therapeutic effects of radial pressure wave therapy devices and high electromagnetic wave induction devices(rPMS) and conventional pulsed ultrasound therapy devices for synovitis associated with knee osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the amount of joint fluid punctured under the ultrasound (measure the amount of joint fluid before the start of treatment and the amount of joint fluid 5 weeks after the start of treatment) and the knee injury and osteoarthritis outcome score (KOOS) questionnaire
Key secondary outcomes
Evaluation of pain (VAS), measurement of knee joint circumference (base of the patella, mid-patella, joint fissure), evaluation of tenderness threshold (measured with an algometer),joint range of motion test (knee extension, knee flexion) measured with a goniometer,manual muscle strength test (knee extension, knee flexion) measured with a hand dynamometer Data analysis is performed using SPSS, which is a data analysis tool
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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 |
Interventions/Control_1
radial pressure wave
Interventions/Control_2
repetitive Pulse Magnetic Stimulation
Interventions/Control_3
Ultrasound therapy device
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who was diagnosed with knee osteoarthritis at the N Clinic and was diagnosed with intra-articular edema, and received 5 times intra-articular injections of sodium hyaluronate (HA) at a pace of once a week, and whose intra-articular effusion does not improve even after arthrocentesis is performed before sodium hyaluronate, or patients whose joint effusion or synovitis does not improve even after treatment at other clinic for more than 3 months
Key exclusion criteria
Patients who are undergoing two treatments at the same time, patients who continue to receive intra-articular HA injections, patients who have undergone focused extracorporeal shockwave therapy or other treatments (e.g., surgery, PRP therapy, APS therapy, MSC therapy, etc.) and whose therapeutic effects are thought to be involved, and patients with metabolic or infectious diseases such as RA
Target sample size
45
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
359-1192/359-1192
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 clinc
Division name
medical office
Zip code
596-0045
Address
3-10-10 Bessho-cho Kishiwada City,Osaka,Japan
TEL
0724-432-4976
Homepage URL
http://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,Shinjyuku-ku,Tokyo,Japan
Tel
03-5273-9807/03-5273-9807
rps-management@list.waseda.jp/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 | 04 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 21 | 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 | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065654
