UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058268 |
|---|---|
| Receipt number | R000060073 |
| Scientific Title | Effects of combined active knee exercise and high-intensity continuous ultrasound on infrapatellar fat pad stiffness and gliding in healthy participants: A randomised, single blind, placebo-controlled crossover trial |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/25 21:21:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of ultrasound therapy on the stiffness and gliding of the infrapatellar fat pad
Acronym
Effects of ultrasound therapy on the stiffness and gliding of the infrapatellar fat pad
Scientific Title
Effects of combined active knee exercise and high-intensity continuous ultrasound on infrapatellar fat pad stiffness and gliding in healthy participants: A randomised, single blind, placebo-controlled crossover trial
Scientific Title:Acronym
Effects of ultrasound therapy on the stiffness and gliding of the infrapatellar fat pad
Region
| Japan |
Condition
Condition
Health persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of combined active knee exercise and ultrasound therapy on the stiffness and gliding of the infrapatellar fat pad in humans
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stiffness of the Infrapatellar fat pad at 10 degrees and 120 degrees knee flexion/Gliding of the infrapatellar fat pad
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Combined active knee exercise and high-intensity continuous ultrasound therapy intervention was performed twice over two days, 5 minutes per session.
Interventions/Control_2
Combined active knee exercise and sham ultrasound therapy intervention was performed twice over two days, 5 minutes per session.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18-30 years without knee pain or limitation in knee joint range of motion.
Key exclusion criteria
- Persons with a history of neurological or knee joint disorders
- Persons who are unable to provide informed consent
- Persons deemed inappropriate for participation by the investigator for any other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Morishita |
Organization
Graduate School of Health Sciences, Josai International University
Division name
Health sciences
Zip code
283-8555
Address
1 Gumyo, Togane City, Chiba Prefecture
TEL
045-53-2225
morishita@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Morishita |
Organization
Graduate School of Health Sciences, Josai International University
Division name
Health Science
Zip code
283-8555
Address
1 Gumyo, Togane City, Chiba Prefecture
TEL
045-53-2225
Homepage URL
morishita@jiu.ac.jp
Sponsor or person
Institute
Graduate School of Health Sciences, Josai International University
Institute
Department
Personal name
Funding Source
Organization
no
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
Ethics Review Board for Research Involving Human Subjects of Josai International University
Address
1 Gumyo, Togane City, Chiba Prefecture
Tel
0475-55-7832
research-c@jiu.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 | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
jglobal.jst.go.jp/detail?JGLOBAL_ID=202309016519040698
Number of participants that the trial has enrolled
20
Results
Infrapatellar fat pad (IFP) stiffness
At 10 degrees knee flexion, stiffness decreased from pre- to immediately post-intervention under high-intensity continuous ultrasound (HICUS).
At 120 degrees, stiffness decreased from pre- to immediately and 15 min post-intervention in the HICUS condition.
IFP Gliding
Improved in the HICUS condition from pre- to immediately and 15 min post-intervention, and in the placebo condition from pre- to immediately post-intervention.
Results date posted
| 2025 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 20 healthy adults (10 men and 10 women) were included in this study. The participants' characteristics were as follows: age 20.3 (1.6) years, height 162.9 (6.7) cm, weight 62.5 (13.1) kg, and BMI 23.4 (3.8) kg/m2 [mean (standard deviation) for all variables].
The inclusion criteria were adults aged between 18 and 30 years without knee pain or limitation in knee joint range of motion.
The exclusion criteria were a history of neurological or knee joint disorders, inability to provide informed consent, or any other condition deemed inappropriate by the principal investigator.
Participant flow
A total of 20 adults (10 men and 10 women) who provided informed consent were enrolled in this study. All participants met the eligibility criteria, and none were excluded. Randomization was performed using a web-based application (RANDOM.ORG), and the participants were allocated to either the intervention-placebo sequence group (n = 10) or the placebo-intervention sequence group (n = 10). There were no dropouts or discontinuations after allocation, and all 20 participants completed both intervention conditions. Consequently, data from all 20 participants were included in the final analysis.
Adverse events
There were no dropouts during the intervention period, and no adverse events were reported in either the High-intensity continuous ultrasound or placebo conditions.
Outcome measures
Stiffness of the infrapatellar fat pad at 10 degrees and 120 degrees of knee flexion
Gliding of the infrapatellar fat pad
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060073
