UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055705 |
|---|---|
| Receipt number | R000063659 |
| Scientific Title | Verification of the Superiority of Radiofrequency Irradiation with Static Stretching over Static Stretching Alone for Hamstring Tightness |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2024/10/02 16:38:04 |
* 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
Verification of the Superiority of Radiofrequency Irradiation with Static Stretching over Static Stretching Alone for Hamstring Tightness
Acronym
Radiofrequency with Static Stretching versus Static Stretching alone for Hamstring Tightness
Scientific Title
Verification of the Superiority of Radiofrequency Irradiation with Static Stretching over Static Stretching Alone for Hamstring Tightness
Scientific Title:Acronym
Radiofrequency with Static Stretching versus Static Stretching alone for Hamstring Tightness
Region
| Japan |
Condition
Condition
Hamstring Tightness
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare the immediate effects of static stretching (SS) performed simultaneously with radiofrequency (RF) therapy to those of SS alone on hamstring flexibility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Extension Angle of Knee Joint as Primary Outcome
Key secondary outcomes
Muscle properties for the Lateral and Medial Hamstrings Muscle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In RF group: Five repetitions (1 min each) of static stretching were performed with 45 sec of rest between each stretch. Two minutes of radiofrequncy is applied before the start of stretching and during the rest period between each stretching set.
Interventions/Control_2
Control group received only SS along with sham RF
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants were eligible for inclusion if they met all of the following criteria: age between 18 and 29 years and asymptomatic tightness in the hamstrings of the dominant leg (lag > 20 degree) on the Active Knee Extension Test
Key exclusion criteria
Trauma to the hip, knee, or back; diagnosis of low back pain; previous hamstring injury; history of any neurological disorder; and recent stretching maneuver.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Usa |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-ogu, Arakawa-ku, Tokyo, Japan
TEL
+81-3-3819-1211
usa@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Usa |
Organization
Faculty of Health Sciences, Tokyo Metropolitan University, Tokyo, Japan
Division name
Division of Physical Therapy
Zip code
116-8551
Address
7-2-10 Higashi-ogu, Arakawa-ku, Tokyo 116-8551, Japan
TEL
+81-3-3819-1211
Homepage URL
usa@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
Address
7-2-10 Higashi-ogu, Arakawa-ku, Tokyo 116-8551, Japan
Tel
+81-3-3819-1211
a-rinri@jmj.tmu.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
| 2024 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/journal/journal-of-bodywork-and-movement-therapies
Number of participants that the trial has enrolled
36
Results
The paper has received its first review. The editor of the journal has asked to apply for UMIN Registration
Results date posted
| 2024 | Year | 10 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The article will be published after the due peer-review process is complete.
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
| 2022 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063659
