UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039898 |
|---|---|
| Receipt number | R000045180 |
| Scientific Title | Randomized controlled trial used press needle for lower limbs muscle tone |
| Date of disclosure of the study information | 2020/03/22 |
| Last modified on | 2023/10/16 06:13:10 |
* 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
Randomized controlled trial used press needle for lower limbs muscle tone
Acronym
Randomized controlled trial used press needle for lower limbs muscle tone
Scientific Title
Randomized controlled trial used press needle for lower limbs muscle tone
Scientific Title:Acronym
Randomized controlled trial used press needle for lower limbs muscle tone
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of acupuncture stimulation on changes in lower limbs muscle tone and the effect of stimulation time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in hip joint movement.
Differences due to stimulation time immediately after and 15 minutes after intervention.
Key secondary outcomes
Verification of reliability of blind test.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Press needle, 15 minutes
Interventions/Control_2
Placebo press needle, 15 minutes
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
General healthy people
Key exclusion criteria
1.Patients who have been diagnosed with lower back and leg pain within six months.
2.Patients with a hip flexion angle of 90 degree or more as measured before intervention.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichirou |
| Middle name | |
| Last name | Hoshi |
Organization
Tukuba international Acupuncture-Moxibushion Institute
Division name
None
Zip code
305-0051
Address
203-10-17-2 Ninomiya, Tukuba-Shi, Ibaraki 305-0051, Japan
TEL
029-897-3150
15dr02@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Shinichirou |
| Middle name | |
| Last name | Hoshi |
Organization
Tukuba international Acupuncture-Moxibushion Institute
Division name
None
Zip code
305-0051
Address
203-10-17-2 Ninomiya, Tukuba-Shi, Ibaraki 305-0051, Japan
TEL
029-897-3150
Homepage URL
15dr02@g.seirei.ac.jp
Sponsor or person
Institute
Tukuba international Acupuncture-Moxibushion Institute
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University of Health Science
Address
2-92 Higashiuzura, Gifu-Shi, Gifu 500-8281, Japan
Tel
058-274-5001
n-naitou@gifuhoken.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 | 03 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045180
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
