UMIN-CTR Clinical Trial

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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