UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038501 |
|---|---|
| Receipt number | 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 16:02:59 |
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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
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
kitakita1215reha@yahoo.co.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043876
