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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038501
Receipt No. R000043876
Scientific Title Effect of low intensity pulsed ultrasound therapy on the Infrapatellar fat pad in knee osteoarthritis
Date of disclosure of the study information 2020/01/01
Last modified on 2020/12/18

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Basic information
Public title Effect of low intensity pulsed ultrasound therapy on the Infrapatellar fat pad in knee osteoarthritis
Acronym Effect of low intensity pulsed ultrasound therapy on the Infrapatellar fat pad in knee osteoarthritis
Scientific Title Effect of low intensity pulsed ultrasound therapy on the Infrapatellar fat pad in knee osteoarthritis
Scientific Title:Acronym Effect of low intensity pulsed ultrasound therapy on the Infrapatellar fat pad in knee osteoarthritis
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of low intensity pulsed ultrasound therapy for infrapatellar fat pad of knee osteoarthritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes (baseline, after treatment, after 10 times of treatment)
1)Glidability of the infrapatellar fat pad
2)thickness change of the infrapatellar fat pad
3)echo intensity of the infrapatellar fat
Key secondary outcomes 1)VAS for walking pain
2) knee extension / flexion range of motion
3) knee extension muscle strength
(baseline, after treatment, after 10 times of treatment)
4)Timed Up & Go Test (TUG)
5)2 steps test
6)Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
7) lequesne index (LI)
8)kujala score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Home exercise+low intensity pulsed ultrasound(LIPUS)
two per week for 5 weeks /Interventions
Interventions/Control_2 Home exercise+sham LIPUS
two per week for 5 weeks / Interventions
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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 40 knees of 40 people who have been diagnosed with knee OA and have pain in front or inside of the knee joint during walking, climbing stairs, or standing up
Key exclusion criteria Rheumatoid arthritis, gouty arthritis, infectious arthritis, history of artificial knee joint replacement on the test side,
History of use of non-steroidal anti-inflammatory drugs (NSAIDs),
Those with symptoms that interfere with exercise (heart disease, uncontrolled hypertension, abnormal blood clotting, bleeding, etc.)
Physiotherapy, acupuncture, steroid oral or joint use in the last 6 months





Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shintaro
Middle name
Last name Kudo
Organization Morinomiya University of Medical Sciences
Division name Faculity of health sciences/Department of physical therapy
Zip code 559-8611
Address 1-26-16Nankokita,Suminoe-ku,Osaka-shi,Osaka
TEL 06-6616-6911
Email kudo@morinomiya-u.ac.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Kitano
Organization Yamamuro Clinic
Division name Division of Physical therapy and Rehabilitation Medicine
Zip code 939-8006
Address 44-1,Yamamuro,Toyama-shi,toyama
TEL 076-492-9922
Homepage URL
Email kitakita1215reha@yahoo.co.jp

Sponsor
Institute Morinomiya University of Medical Sciences
Institute
Department

Funding Source
Organization no organaization
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 1-26-16Nankokita,Suminoe-ku,Osaka-shi,Osaka
Tel 06-6616-6911
Email kudo@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
2020 Year 01 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 Completed
Date of protocol fixation
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 07 Month 04 Day
Anticipated trial start date
2019 Year 07 Month 15 Day
Last follow-up date
2020 Year 08 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
2019 Year 11 Month 06 Day
Last modified on
2020 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043876

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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